SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA..
Device Facts
| Record ID | K111390 |
|---|---|
| Device Name | SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA.. |
| Applicant | Cendres & Metaux SA |
| Product Code | NHA · Dental |
| Decision Date | Sep 12, 2011 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 872.3630 |
| Device Class | Class 2 |
Indications for Use
The SFI-Bar® is intended to be used with the implant manufacturer's (TABLE A) implant to provide support for fixation of overdentures.
Device Story
SFI-Bar® is a dental abutment system providing a connection between dental implants and removable overdentures. It consists of an implant adapter (abutment) and a stress-free bar. The adapter is screwed into the dental implant; the bar provides primary splinting and stabilization of implants. Used in the oral cavity by dental professionals. The device counters dislodging forces, distributes shear forces, and provides resilience compensation for the denture. It supports immediate loading in the mandible if specific criteria are met: implant manufacturer permits immediate loading, no guided bone regeneration required, minimum 35 Ncm insertion torque, and pull-off strength < 20 N during osseointegration. The system benefits patients by providing a secure, stable fixation for removable overdentures.
Clinical Evidence
No clinical data. Performance was established through non-clinical testing, including validation of sterilization, evaluation of manual disinfection procedures, and functional testing based on literature research. The evaluation followed FDA guidance for root-form endosseous dental implants and abutments.
Technological Characteristics
Materials: Wrought Titanium-6Aluminium-4Vanadium ELI Alloy (ASTM F 136, UNS R 56401). Design: Machined, screw-retained implant adapter and stress-free bar. Connectivity: Mechanical interface with specific dental implant platforms (Thommen, Neoss, Straumann). Manufacturing: CNC machined, validated cleaning process. Non-sterile packaging.
Indications for Use
Indicated for patients requiring fixation of removable overdentures supported by compatible dental implants (Thommen SPI Element, Neoss ProActive, or Straumann ITI systems).
Regulatory Classification
Identification
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
Special Controls
*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
Predicate Devices
Submission Summary (Full Text)
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#### 2011 12
K1113910
## Attachment: 510(k) Summary
## Applicant's Name and Address
Submitter:
CENDRES+METAUX SA Rue de Boujean 122 2501 Biel/Bienne, Switzerland Phone: +41 58 360 20 00 +41 58 360 20 10 Fax:
Contact Person:
Tanja Bongni Consultant Regulatory Affairs
Date of Submission:
May 09, 2011
#### Name of the Device
Trade Name: Common Name: Classification Name: Regulation Number:
SFI-Bar® Abutment. Dental. Endosseous implants Endosseous Dental Implant Abutment 21 CFR 872.3630
#### Legally Marketed Device to which Equivalence is Claimed (Predicate Device)
Predicate Device(s):
K073628, K083876, K102382
#### Description of the Device
Device Description:
The SFI-Bar® provides the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI-Bar® consists of an implant adapter (abutment) and a stress-free bar for the fixation of removable overdentures. The implant adapter is screwed into the dental implant.
The implant adapter (abutment) fit the Thommen SPI® Element Platform Ø 4.0 mm / the Neoss ProActive Implant Ø 3.5 / 4.0 / 4.5 / 5.0 / 5.5 mm and the Straumann dental implants / ITI Dental Implant System® Standard Ø 4.1 and Ø 4.8 mm / Standard Plus Ø 4.1 mm and Ø 4.8 mm / Tapered Effect Ø 4.1 and Ø 4.8 mm and Regular Neck (RN) Ø 4.8 mm.
The implants (min. 2) in the mandible can be fitted with the SFI-Bar® immediately after implantation, provided the following criteria are met:
- Implant manufacturers permit immediate loading in their -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------system.
- No necessity for simultaneous guided bone regeneration; -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------implants surrounded on all sides by local bone.
- Implant insertion torque min. 35 Ncm.
- All parts are sterilized or disinfected.
- Pull-of strength during osseointegration < 20 N.
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K111390
#### Intended Use of the Device:
The SFI-Bar® is intended to be used with the implant manufacturer's (TABLE A) implant to provide support for fixation of overdentures.
TABLE A Compatible Commercial Implant Manufacturers:
| Implant Company | Implant System | Implant Platform<br>Diameter |
|--------------------|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Thommen Medical | SPI® Element<br>Platform | 4.0 mm |
| Neoss | Neoss ProActive<br>Implant | 3.5 / 4.0 / 4.5 / 5.0 /<br>5.5 mm |
| Institut Straumann | ITI Dental Implant<br>System® | Standard 4.1 and 4.8<br>mm /<br>Standard Plus 4.1 and<br>4.8 mm /<br>Tapered Effect 4.1 and<br>4.8 mm /<br>Regular Neck (RN) 4.8<br>mm |
### Summary Technological Characteristics:
Comparison /Compatibility Substantially Equivalence: The proposed labelling change to the SFI-Bar® is substantially equivalent to the currently marketed predicate devices. The intended use, basic design, fundamental operating principles and manufacturing procedures are the same as the predicate device.
The material of the implant adapters conform to ASTM F 136, Wrought Titanium-6Aluminium-4Vanadium ELI Alloy for Surgical Implant applications (UNS R 56401). The parts for the SFI-Bar® System are manufactured from wires.
The proposed implant adapters are substantially equivalent to the currently marketed predicate devices. The intended use, basic design, fundamental operating principles and manufacturing procedures are the same as the predicate device.
To ensure compatibility the following process was carried out: The implant adapters are developed and manufactured in close cooperation with the implant companies (see TABLE A, column "Implant Company").
There are Quality Agreements between CENDRES+METAUX and the implant companies in place. Those agreements handle among other things the Design Control, Change Control, Complaint Handling and Post Market Surveillance.
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TABLE B summarizes the substantial equivalence comparison to the predicate device:
| TABLE B Substantial Equivalence Comparison to Predicate Devices: | | |
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| Attribute | Candidates | Predicate Device | Predicate Device |
|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | SFI-BarⓇ | SFI-BarⓇ<br>K083876,<br>K102382 | RN synOctaⓇ<br>K073628 |
| Design / construction | Machined, screw-retained | Machined, screw-retained | Machined, screw-retained |
| Anatomical Site | Oral Cavity | Oral Cavity | Oral Cavity |
| Platform compatibility | ITI Dental Implant<br>System®: Standard Ø 4.1 mm and Ø 4.8 mm /<br>Standard Plus Ø 4.1 mm and Ø 4.8 mm/<br>Tapered Effect Ø 4.1 mm and Ø 4.8 mm /<br>Regular Neck (RN) Ø 4.8 mm | ITI Dental Implant<br>System®: Standard Ø 4.1 mm and Ø 4.8 mm /<br>Standard Plus Ø 4.1 mm and Ø 4.8 mm/<br>Tapered Effect Ø 4.1 mm and Ø 4.8 mm/<br>Regular Neck (RN) Ø 4.8 mm | ITI Dental Implant<br>System®:<br>Standard Ø 4.8 mm RN<br>and Ø 6.5 mm WN /<br>Standard Plus Ø 4.8 mm<br>and Ø 6.5 mm WN/<br>Tapered Effect Ø 4.8 mm<br>and Ø 6.5 mm WN |
| | Neoss ProActive Implant:<br>Ø 3.5 / 4.0 / 4.5 / 5.0 /<br>5.5 mm | Neoss ProActive Implant:<br>Ø 3.5 / 4.0 / 4.5 / 5.0 /<br>5.5 mm | |
| | Thommen Implant System:<br>SPI® Element Platform Ø<br>4.0 mm | Thommen Implant System:<br>SPI® Element Platform Ø<br>4.0 mm | |
| Device Material | Wrought Titanium-<br>6Aluminium-4Vanadium<br>ELI Alloy for Surgical<br>Implant applications | Wrought Titanium-<br>6Aluminium-4Vanadium<br>ELI Alloy for Surgical<br>Implant applications | Titanium abutment,<br>Ceramicor sleeve |
| Manufacturer | CENDRES+METAUX SA | CENDRES+METAUX SA | Institut Straumann AG |
| Indication for Use | The SFI-Bar® is intended<br>to be used with the<br>implant manufacturer's<br>(see TABLE A) implant to<br>provide support for fixation<br>of overdentures. | The SFI-Bar® is intended<br>to be used with the<br>implant manufacturer's<br>(see TABLE A) implant to<br>provide support for fixation<br>of overdentures. | Abutments are intended to<br>be placed into dental<br>implants to provide<br>support for prosthetic<br>reconstructions such as<br>crowns, bridges and<br>overdentures. |
| Operating principle /<br>Basic Design | Impression taking:<br>optional,<br>preassembled (plug-in<br>connection).<br>Abutment implant<br>connection: screw fixation.<br>Connecting principle to<br>overdenture: retentive<br>system.<br>Bar fixation on implant:<br>screwed.<br>Function: stabilization and<br>primary splinting of<br>implants.<br>Countering forces that<br>would dislodge the | Impression taking:<br>optional,<br>preassembled (plug-in<br>connection).<br>Abutment implant<br>connection: screw fixation.<br>Connecting principle to<br>overdenture: retentive<br>system.<br>Bar fixation on implant:<br>screwed.<br>Function: stabilization and<br>primary splinting of<br>implants.<br>Countering forces that<br>would dislodge the | Impression taking:<br>required.<br>Abutment Implant<br>connection: Screw fixation.<br>Bar connection: soldered.<br>Connecting principle to<br>overdenture: retentive<br>system.<br>Bar fixation on implant:<br>screwed.<br>Countering forces that<br>would dislodge the |
| | | | |
| Attribute | Candidates | Predicate Device | Predicate Device |
| | denture, distribution of<br>shear forces, resilience<br>compensation. | denture, distribution of<br>shear forces, resilience<br>compensation. | denture, distribution of<br>shear forces, resilience<br>compensation. |
| | Cleaning procedures for<br>patient: common<br>procedure for oral hygiene. | Cleaning procedures for<br>patient: common<br>procedure for oral hygiene. | Cleaning procedures for<br>patient: common<br>procedure for oral hygiene. |
| | Patient handling:<br>common cleaning and<br>insertion of denture. | Patient handling:<br>common cleaning and<br>insertion of denture. | Patient handling:<br>common cleaning and<br>insertion of denture. |
| Shelf life | 95% after 10 years | 95% after 10 years | 95% after 10 years |
| Packaging, materials and<br>processes | Produced on process<br>orientated CNC machines.<br>The last step is a validated<br>cleaning process (same<br>processes). | Produced on process<br>orientated CNC machines.<br>The last step is a validated<br>cleaning process (same<br>processes). | Produced on process<br>oriented CNC machines.<br>The last step is a validated<br>cleaning process (same<br>process). |
| | Packaging: dental blister,<br>non-sterile. | Packaging: dental blister,<br>non-sterile. | Packaging:<br>non-sterile. |
| Abutment / implant<br>adapter used in context<br>with the immediate<br>loading. | Yes (this submission). | No. | Yes. Abutment cleared for<br>immediate loading. |
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K111390
Performance Data:
Validation of Sterilization for the metallic components, evaluation of the intended manual disinfection procedure with SFI-Bar® Retention inserts G. application and functional testing based on literature research have been conducted to evaluate the performance characteristics of the SFI-Bar®. The test methods used were the same as in the predicate device. Testing has shown that the SFI-Bar® is equivalent in performance characteristics to the predicate SFI-Bar®. The acceptance criteria were met.
Summary of Testing to Demonstrate Safety and Effectiveness / Conclusion:
Non-clinical test data was used to support the substantially equivalence claim. Clinical testing was not necessary. Non-clinical testing consisted of analysis of platforms to identify worst-case test samples. Fatigue testing was not done as the basic design is the same than the predicate device. The evaluation was based on FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." Application and functional tests are based on the predicate device and literature research. The summary of technological characteristics indicate that the device is safe and effective for its intended use and performs as well or better than the predicate devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Tanja Bongni Consultant Regulatory Affairs Cendres-Metaux SA Rue de Boujean 122 Biel/ Bienne Switzerland 2501
SEP 12 2011
Re: K111390
Trade/Device Name: SFI-Bar® Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 23, 2011 Received: August 29, 2011
Dear Ms. Bongni:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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## Page 2 - Ms. Bongni
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MicdicalDevices/Safety/Reportal/roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KIIBTO
# Attachment: Indications for Use Statement
Device Name:
SFI-Bar®
#### Indications for Use:
The SFI-Bar® is intended to be used with the implant manufacturer's implant (TABLE a) to provide support for fixation of overentures.
| Implant Company | Implant System | Implant Platform Diameter |
|--------------------|----------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Institut Straumann | ITI Dental Implant System® | Standard 4.1 and 4.8 mm /<br>Standard Plus 4.1 and 4.8 mm /<br>Tapered Effect 4.1 and 4.8 /<br>Regular Neck (RN) 4.8 mm |
| Thommen Medical | SPI® Element Platform | 4.0 mm |
| Neoss | Neoss ProActive Implant | 3.5 / 4.0 / 4.5 / 5.0 / 5.5 mm |
TABLE a Compatible Commercial Implant Manufacturers
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Suan Suany
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K111390
Prescription Use x
OR
Over-The-Counter Use
