Instructions for Use (ENG)

Last revision date: 05/02/2020 Revisión: 3

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Introduction

This instructions show indications, contraindications, warnings and methods of use of the Delta Abutments system.

Warnings

Following warnings apply globally to the whole Delta Abutments System.

In case of doubt please contact the manufacturer.

The product is designed to be single-used. Do not reuse product.

Mechanical properties of a reused product may have been altered and the implant connection damaged.

Sinumetrics Systems can not guarantee the correct performance of a reused product.

Delta Abutments Systems clinical abutments must only be used by odontology professionals specialized in implantology and prosthetics.

If Delta Abutment systems is used by non specialised personnel , possible defects as well as new material reclaim will not be covered by guarantee.

Sinumetrics Systems recommends procedural use of dental product by the customer to guarantee the processes used are performed as intended. These processes include: Inspection of purchased material, surgical planification, cleansing, sterilisation, clinical case review, surgical procedure, systematic review plan and customer complaints among other.

For the correct use of Delta Abutment System it is recommended to use indicated instrumentation.

Intended use

Delta Abutment System’s intended use is to successfully complete dental prostheses restoration processes in the clinical or laboratory environment.

Contraindications

Delta Abutment systems is not intended to be used on patients suffering from allergies or other harmful reactions to materials of the system. Please read carefully table 1 to identify the component meant to be used and the material it’s made of. According to customer protocols, Sinumetrics Systems recommends compiling all the important information about the patient to avoid this potential negative effects.

Some patient’s habits such as dental hygiene and smoking can affect negatively to abutment’s system’s intended use. It is recommended to inform the patient about the importance of healthy dental habits.

Compatibility with other products

Delta Abutment system is designed and tested so it’s intended use is meant to be used with other products from other brands. Please check table 2 regarding compatibilities and make sure the product that has been planned to be used is suitable for the dental implants the patient is using.

Information regarding cleaning and sterilisation

Cleaning

Cleaning is performed by Sinumetrics Systems. In case the customer needs to perform cleaning according his or her procedures, it is recommended to use neutral detergent, whether is manual or automated cleaning. 

Sterilisation

Sinumetrics Systems does not perform Sterilisation to Delta Abutment system. Sinumetrics recommends the following indications to sterilise the medical device (in accordance with standard EN ISO 17665-1:2006):

  • To correctly sterilise the medical device, original packaging must be disposed and put on a double bag of sterilisation paper roll thermosealed at 175ºC. (This settings have been validated with AMCOR BOP MIXED ROLLS in paper 60gr/m2 and film PE-PP (12/40 μm) 53gr/m2)  and a thermosealing machine Matachana 680 DE-V).
  • To correctly sterilise medical devices, pre-vacuum autoclaving has to be performed at 121ºC during 30 minutes with a drying time of 15 minutes. (This settings have been validated in a Matachana M30-B autoclave machine)

This processes are validated by outsourced analysis laboratories. Other equivalent sterilization methods can be used as long as they are to be validated by the user according to EN ISO 17665-1:2006 and EN ISO 11607-1:2017.

Products

01-Scanbody-Intended use and indications for use

Intended use of scanbodies is laboratory work model scans to determine dental implant position.

Scanbodies are linked to digital files associated to it’s scanning system. Scanbodies are not intended to be used with the patient. They can only be used with laboratory dental model. Scanbodies must be connected to the analogs of the work model and scan them.It is necessary to check scanbodies correct fitting for accurate scanning. It is highly recommended to check scanbodies wear out. If, due to wear, connection does not fit accordingly, scanning information may be wrong.

02-Analog-Intended use and indications for use

Intended use of analogs is laboratory model creation with the exact position of the analogs where implants should be in mouth. Analog can be reused, however the customer must check no damage has altered the connection. I this is so this can lead to wrong measurements and incorrect prostheses adjustments.

03-Laboratory Screw-Intended use and indications for use

Intended use of the lab screw is the manipulation of the dental prosthesis with ease in the laboratory dental model. The use of this screw is specifically intended to work with restorations which use acrylic resin in prosthesis manufacturing.

04-05-Castable-Intended use and indications for use

Intended use of castable is the manufacturing of prostheses using casting through lost wax technique. 

Castable replicates connection and has retentions for wax to adhere properly. Casting is a manual process in which several variables intervene. Responsability for castable use is on the customer.

06-Open tray transfer-Intended use and indications for use

Intended use of open tray transfer is correct transference of the position of the implants from patient’s mouth to a work model.Open tray transfer is indicated to be used in the open tray measuring procedure.

07-Closed tray transfer-Intended use and indications for use

Intended use of closed tray transfer is the correct transference of he position of the implants from patient’s mouth to a work model. Closed tray transfer  is indicated to be used in the closed tray measuring procedure.

08-Implant cap-Intended use and indications for use

Intended use of implant cap is to isolate the connection of the implant from possible damage or contamination during surgical procedure. It is indicated for rehabilitations that use immediate load or measuring techniques and other procedures that may be performed during implant positioning surgery.

09-Clinical screw-Intended use and indications for use

The intended use of clinical screw is fixing abutment and prosthesis to the implant. It is recommended to screw the product at the recommended maximum torque indicated in table.3. It is recommended to apply recommended torque and 10 minutes later apply that torque again.

10-Millable abutment-Intended use and indications for use

The intended use of the millable abutment is to create an artificial custom hand-made stump.

It is indicated to perform this procedure as far as possible from the patient. The scrap metal may be harmful to the patient.

11-Temporary abutment-Intended use and indications for use

The intended use of the temporal abutment is to support provisional restorations made in acrylic resin.

To manufacture this restorations the abutment can be milled to desired shape. It is indicated to perform this procedure as far as possible from the patient. The scrap metal may be harmful to the patient.

12-Healing Abutment-Intended use and indications for use

The intended use of the healing abutment is to protect the connection of the implant during implant stability phases of primary and secondary stability. Additionally it’s rounded shape is meant for the gingiva to recover safely. The recommended maximum torque is indicated in table.3. It is recommended to apply recommended torque and 10 minutes later apply that torque again.

13-14-15-Multiunit abutment-Intended use and indications for use

Intended use of the Multiunit abutment is to be used as a base for fixed screw restorations.

The recommended maximum torque is indicated in table.3. It is recommended to apply recommended torque and 10 minutes later apply that torque again.

Product labeling indicates screw metrics, it’s maximum torque recommended for its screw is idicated in table.3.

Additionally, the abutment final restorations has to be screwed with screw REF:090931 which has an M1.4 class thread. The recommended maximum torque for this screw is indicated in table.3.

16-17-18-19-Interface-Intended use and indications for use

Intended use of the interface is to create an intermediate connection for cemented based restorations. The client must plan the use for these interfaces taking into account which implants are in patient’s mouth and which type of restoration must be crafted, whether it is single or multiple.

20-Locator-Intended use and indications for use

Intended use for locator is anchoring of implant supported bars with removable provisional prosthetics.

Locator has an M2.0 class thread. The recommended maximum torque for this screw is indicated in table.3.

Label indications

  1. Product brand
  2. Reference of the product
  3. LOT number
  4. Manufacturing date
  5. Warnings
  6. Online site for instructions for use 
  7. CE marking and Notified body code (0123, TÜV-SÜD)
  8. Symbol indications (non reusable, non sterile. etc.)
  9. Manufacturer and it’s address. (Sinumetrics Systems S.A.L. C/Tecnica 75, 08740, Sant Andreu de la Barca, Barcelona, Spain.)
  10. Date of the last revision of the label

Information Tables

Table.1 Information about components of Delta Abutment System

ProductCóde(*)Class according MDD CE 93/42Material
Scanbody01RRRRN/AAluminum
Analog02RRRRN/AStainless steel 304 L
Laboratory Screw03RRRRN/AStainless steel 304 L
Rotary Castable04RRRRN/APOM
Anti-Rotary Castable05RRRRN/APOM
Open tray transfer06RRRRIIaTitanium g.V
Closed tray transfer07RRRRIIaTitanium g.V
Implant cap08RRRRIIaTitanium g.V
Clinical screw09RRRR
29RRRR
IIbTitanium g.V
Millable abutment10RRRRIIbTitanium g.V
Temporary abutment11RRRR
22RRRR
IIbTitanium g.V
Healing Abutment12RRRRIIbTitanium g.V
Multiunit abutment13RRRR
14RRRR
15RRRR
IIbTitanium g.V
Rotary Interface 0,5mm16RRRR
17RRRR
18RRRR
19RRRR
26RRRR
38RRRR
IIbTitanium g.V
Locator20RRRRIIaTitanium g.V

Code expressed with letter R refers to the compatible connection shown in table.2

Table.2 Compatibility references naming

0111compatible with 3i Certain 3.4
0112compatible with 3i Certain 4.1
0113compatible with 3i Certain 5.0
0121compatible with 3i Externa 3.4
0122compatible with 3i Externa 4.1
0123compatible with 3i Externa 5.0
0211compatible with Adin Interna 3.5
0311compatible with Astra Tech Yellow
0312compatible with Astra Tech Aqua
0313compatible with Astra Tech Lilac
0321compatible with Astra Evo 3.6
0322compatible with Astra Evo 4.2
0323compatible with Astra Evo 4.8
0324compatible with Astra Evo 3.0
0331compatible with Astra Evo Multiunit
0341compatible with Astra Pilar 20º
0342compatible with Astra Pilar 45º
0411compatible with Avinent Externa 3.5
0412compatible with Avinent Externa 4.0
0421compatible with Avinent Interna 3.5
0422compatible with Avinent Interna 4.0
0511compatible with Bego Interna 3.75
0512compatible with Bego Interna 4.5
0611compatible with BioHorizons Interna 3.0
0612compatible with BioHorizons Interna 3.5
0613compatible with BioHorizons Interna 4.5
0614compatible with BioHorizons Interna 5.7
0621compatible with BioHorizons Externa 3.5
0622compatible with BioHorizons Externa 4.0
0623compatible with BioHorizons Externa 5.0
0624compatible with BioHorizons Externa 6.0
0711compatible with BTI Externa 3.5
0712compatible with BTI Externa 4.1
0713compatible with BTI Externa 5.5
0721compatible with BTI Interna 3.5
0722compatible with BTI Interna 4.0
0723compatible with BTI Interna 5.5
0731compatible with BTI Unit 4.0
0732compatible with BTI Unit 5.5
0811compatible with Mis Interna NARROW
0812compatible with Mis Interna 3.75
0813compatible with Mis Interna 4.5
0814compatible with Mis Interna 5.7
0821compatible with Mis Multiunit
0822compatible with Mis Multiunit Angulado
0911compatible with Nobel Active NP
0912compatible with Nobel Active RP
0921compatible with Nobel Branemark NP
0922compatible with Nobel Branemark RP
0923compatible with Nobel Branemark WP
0931compatible with Nobel Multiunit RP
0932compatible with Nobel Multiunit WP
0941compatible with Nobel Replace NP
0942compatible with Nobel Replace RP
0943compatible with Nobel Replace WP
0944compatible with Nobel Replace 6.0
1011compatible with Straumann Bone Level NC
1012compatible with Straumann Bone Level RC
1021compatible with Straumann Tissue Level RN
1022compatible with Straumann Tissue Level WN
1031compatible with Straumann Pilar Tissue Level RN
1032compatible with Straumann Pilar Tissue Level WN
1041compatible with Straumann Pilar Bone level
1111compatible with Sweden Martina Externa 3.3
1112compatible with Sweden Martina Externa 4.1
1113compatible with Sweden Martina Externa 5.0
1121compatible with Sweden Martina Kohno 3.3
1122compatible with Sweden Martina Kohno 3.8
1123compatible with Sweden Martina Kohno 4.25
1124compatible with Sweden Martina Kohno 5.0
1211compatible with Zimmer TSV Green
1212compatible with Zimmer TSV Purple
1213compatible with Zimmer TSV Yellow
1311compatible with Dentsply Xive 3.4
1312compatible with Dentsply Xive 3.8
1313compatible with Dentsply Xive 4.5
1321compatible with Dentsply Xive TG 4.8
1511compatible with Camlog Interna 3.8
1612compatible with Eckermann Interna 4.3
1711compatible with Galimplant Interna
1721compatible with Galimplant Pilar Recto Rotatorio
1722compatible with Galimplant Pilar Recto Antirrotatorio
1731compatible with Galimplant Externa 4.0
1732compatible with Galimplant Externa 5.0
1811compatible with Implant Direct Legacy 3.0
1911compatible with Klockner Essential 4.5
1912compatible with Klockner Essential 6.0
1921compatible with Klockner Octa 4.5
1922compatible with Klockner Octa 6.0
1931compatible with Klockner SK2 3.3
1932compatible with Klockner SK2 4.2
1933compatible with Klockner SK2 5.5
1941compatible with Klockner Vega MV
1942compatible with Klockner Vega NV
1943compatible with Klockner Vega RV
1951compatible with Klockner SH
2011compatible with Megagen Anyridge 3.3
2012compatible with Megagen Anyridge 3.75
2021compatible with Megagen Octa 3.8
2022compatible with Megagen Octa 4.8
2111compatible with Neodent CM Interna
2121compatible with Neodent GM Interna 4.8
2131compatible with Neodent CM Pilar 3.5
2132compatible with Neodent CM Pilar AR
2133compatible with Neodent CM Pilar RO
2141compatible with Neodent GM Pilar Micro
2142compatible with Neodent GM Pilar Mini
2151compatible with Neodent Externa 3.3
2152compatible with Neodent Externa 4.3
2153compatible with Neodent Externa 5.1
2211compatible with OXY Multiunit 5.0
2311compatible with Phibo Aurea Evo 3.5
2312compatible with Phibo Aurea Evo 4.3
2313compatible with Phibo Aurea Evo 5.4
2321compatible with Phibo TSA S3
2322compatible with Phibo TSA S4
2323compatible with Phibo TSA S5
2331compatible with Phibo TSH S2
2332compatible with Phibo TSH S3/S4
2333compatible with Phibo TSH S5
2341compatible with Phibo ConHex 4.75
2411compatible with Samo Interna 4.2
2511compatible with Anthogyr Axiom BL 2.8
2512compatible with Anthogyr Axiom BL
2521compatible with Anthogyr Axiom TL
2531compatible with Anthogyr Axiom MultiLevel
2611compatible with Ziacom Interna 4.0
2612compatible with Ziacom Interna 5.0
2621compatible with Ziacom Externa 3.3
2622compatible with Ziacom Externa 4.0
2623compatible with Ziacom Externa 5.0
2631compatible with Ziacom Zinic NP
2632compatible with Ziacom Zinic RP
2633compatible with Ziacom Zinic WP
2711compatible with JD Evolution S
2712compatible with JD Evolution
2713compatible with JD Evolution Plus+
2721compatible with JD Icon UltraS
2811compatible with Microdent Genius 3.0
2812compatible with Microdent Genius 3.5
2813compatible with Microdent Genius 4.0
2814compatible with Microdent Genius 4.5
2815compatible with Microdent Genius 5.0
2821compatible with Microdent System 3.5
2822compatible with Microdent System 4.2
2823compatible with Microdent System 5.1
2824compatible with Microdent System 5.6
2831compatible with Microdent Universal 3.5
2832compatible with Microdent Universal 4.1
2833compatible with Microdent Universal 5.1
2834compatible with Microdent Universal 5.6
2841compatible with Microdent Trylogic 3.8
2842compatible with Microdent Trylogic 4.3
2843compatible with Microdent Trylogic 5.1
2844compatible with Microdent Trylogic 5.5
2851compatible with Microdent EK 3.5
2852compatible with Microdent EK 4.5
2853compatible with Microdent EK 5.7
2911compatible with GMI Frontier RP
2912compatible with GMI Frontier WP
2921compatible with GMI Phoenix Estrecha
2922compatible with GMI Phoenix Estándar
2923compatible with GMI Phoenix Ancha
2924compatible with GMI Phoenix Extra-Ancha
2931compatible with GMI Avantgard RP
2932compatible with GMI Avantgard WP
2941compatible with GMI Monolith
3011compatible with TBR Infinity 3.5
3012compatible with TBR Infinity 4.0
3013compatible with TBR Infinity 5.0
3021compatible with TBR Infinity Z1 3.5
3022compatible with TBR Infinity Z1 4.0
3023compatible with TBR Infinity Z1 5.0
3111compatible with Paltop Internal Hex Narrow
3112compatible with Paltop Internal Hex Standard
3113compatible with Paltop Internal Hex Wide
3121compatible with Paltop Conical
3211compatible with Radhex Interna IS
3212compatible with Radhex Interna IM
3221compatible with Radhex Externa ES
3222compatible with Radhex Externa EM
3311compatible with Intralock Gold&Blue Gs
3312compatible with Intralock Gold&Blue Gw
3321compatible with Intralock InDex Estrecho
3322compatible with Intralock InDex Estándar
3323compatible with Intralock InDex Ancha
3331compatible with Intralock IntraHex 3.5
3332compatible with Intralock IntraHex 4.5
3341compatible with Intralock UniHex
3351compatible with Intralock Flatone 3.5
3352compatible with Intralock Flatone 5..0
3411compatible with Alpha Bio IH 3.75/4.2/5.0
3421compatible with Alpha Bio CHC NIce
3422compatible with Alpha Bio CHC Ice
3511compatible with Mozo Grau Inhex Mini
3512compatible with Mozo Grau Inhex STD
3521compatible with Mozo Grau Osseus Mini
3522compatible with Mozo Grau Osseus STD
3621compatible with Dentium Supeprline/Implantum

Please check the reference you plan to use exists before ordering. Check online catalog or contact Sinumetrics Systems. Not all cross references exist for all components.

Table.3 Maximum torque according to M class thread.

M classTorque [N·cm]
M1.415
M1.620
M1.825
M2.030
M2.540