SFI-BAR
Device Facts
| Record ID | K131526 |
|---|---|
| Device Name | SFI-BAR |
| Applicant | Cendres & Metaux SA |
| Product Code | NHA · Dental |
| Decision Date | Sep 23, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3630 |
| Device Class | Class 2 |
Intended Use
The SFI-Bar® is intended to be used with the implant manufacturer's (Table 1) implant to provide support for fixation of overdentures.
Device Story
SFI-Bar® is a dental implant abutment system designed to connect dental implants to removable overdentures. The device consists of an implant adapter (abutment) and a stress-free bar. The adapter is screwed into a compatible dental implant; the bar provides a retentive system for the overdenture. Used in dental clinics by dentists/prosthodontists. The device facilitates stable fixation of removable prostheses, improving patient oral function and quality of life. It is provided non-sterile and requires standard cleaning procedures for oral hygiene.
Clinical Evidence
No clinical data. Safety and effectiveness supported by non-clinical bench testing, including torque tests, application testing, and functional testing. Evaluation based on FDA guidance for Root form Endosseous Dental Implants and Endosseous Dental Implant Abutments.
Technological Characteristics
Materials: Titanium-6Aluminium-4Vanadium ELI Alloy (ASTM F 136). Design: Machined and anodized implant adapters. Connection: Screw fixation to dental implants. Energy source: None (mechanical). Connectivity: None. Sterilization: Non-sterile (Dentalblister packaging).
Indications for Use
Indicated for use with specific compatible dental implant systems (Straumann, Thommen, Neoss, BioHorizons) to provide support for the fixation of removable overdentures in patients requiring dental implant-supported prosthetics.
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
- SFI-Bar (K083876)
- SFI-Bar (K111390)
- BioHorizons Tapered Internal Implant System (K071638)
- The Prodigy System Dental Implants (K042429)
- BioHorizons Single-stage Implant (K073268)
- BioHorizons Single-stage Implant Systems (K053152)
- BioHorizons Internal Implant System (K073282)
Related Devices
- K102382 — SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT · Cendres & Metaux SA · Dec 3, 2010
- K132814 — SFI-BAR IMPLANT ABUTMENTS · Sterngold Dental, LLC · Feb 25, 2014
- K083876 — SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT · Cendres & Metaux SA · Feb 26, 2010
- K130183 — SFI BAR ABUTMENTS · Sterngold Dental, LLC · Jul 7, 2013
- K193404 — UF(II) Bar holder abutment · Dio Corporation · May 18, 2020
Submission Summary (Full Text)
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KBIS26
Image /page/0/Picture/1 description: The image shows a logo with the text "CENDRES+ MÉTAUX". To the left of the text is a stylized symbol that appears to be a combination of the letters 'C' and 'M'. The text is in a bold, sans-serif font, with "CENDRES" on top and "MÉTAUX" below it. The overall design is simple and modern.
May 23, 2013
Image /page/0/Picture/4 description: The image shows a logo with the letters "CM" on the left and the words "CENDRES" and "MÉTAUX" on the right. The letters "CM" are in a bold, sans-serif font and are stacked on top of each other. The word "CENDRES" is in a smaller, sans-serif font and is stacked on top of the word "MÉTAUX". The logo is black and white.
Traditional 510(k) - SFI-Bar® 510(k) Summary
May 23, 2013
### 510(k) Summary
#### Applicant's Name and Address
Submitter:
Rue de Boujean 122 2501 Biel/Bienne, Switzerland Phone: +41 58 360 20 00 Fax: +41 58 360 20 10
Cendres + Métaux SA
Tanja Bongni Regulatory Affairs Manager
Date of Submission:
#### Name of the Device
Contact Person:
Trade Name: Common Name: Classification Name: Regulation Number:
Predicate Device(s):
SFI-Bar Br Abutment, Dental, Endosseous implants Endosseous Dental Implant Abutment 21 CFR 872.3630
#### Legally Marketed Device to which Equivalence is Claimed (Predicate Device)
May 23, 2013
K083876, K111390, K071638, K042429, K073268, K053152, K073282
## 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 (abutinent) 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 Plattorn Ø 4.0 mm / the Neoss ProActive Implant Ø 3.5 / 4.0 / 4.5 / 5.0 / 5.5 mm and the Straumann cental implants / ITI Dental Implant System@ Standard Ø 4.1 and Ø 4.8 mm / Standard Plus Ø 4.1 mm and 0 4.8 mm / Tapered Effect 0 4.1 and 0 4.8 mm and Regular Neck (RN) Ø 4.8 mm and the BioHorizons Implant Systems Tapered Internal Implants / Internal Implants - bone level / Single-stage Implants - tissue level (Implant Platform: Ø 3.5 mm, Ø 4.5 mm, Ø 5.7 mm).
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Image /page/1/Picture/0 description: The image shows the logo for Cendres+Metaux. The logo consists of a stylized letter "C" on the left, followed by the text "CENDRES+" on the top line and "MÉTAUX" on the bottom line. The text is in a bold, sans-serif font.
May 23, 2013
Image /page/1/Picture/3 description: The image shows a logo with the text "CENDRES+ METAUX". To the left of the text is a stylized letter "M". The text is stacked, with "CENDRES+" on top and "METAUX" on the bottom. The logo is black and white.
Traditional 510(k) - SFI-Bar® 510(k) Summary
May 23, 2013
Intended Use of the Device:
The SFI-Bar® is intended to be used with the implant manufacturer's (Table 1) implant lo provide support for lixation of overdentures.
Table 1 Compatible Commercial Implant Manufacturers:
| Implant Manufacturer | 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 mm /<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 |
| BioHorizons | Tapered internal Implant - bone<br>level | Ø 3.5 mm, Ø 4.5 mm, Ø 5.7 mm |
| | Internal Implants -bone level | |
| | Single-stage Implants - tissue<br>level | |
#### Summary Technological Characteristics:
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 devices.
The material of the implant adapters conform to ASTM F 136, Whought Titanium-6Aluminium-4Vanadium ELI Alloy for Surgica! Implant applications (UNS R 56401). The parts for the SFI-Bar® System are rnanufactured from wires.
#### Comparison /Campatibility Substantially Equivatence:
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 1, column "Implant Company").
There are Quality Agreements between Cendres-Mistaux and the implant companies in place. Those agreements handle arnong other things the Design Control. Change Control, Complaint Handling and Post Market Surveillance,
Table 2 summarizes the substantial equivalence comparison to the predicate device:
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May 23, 2013 100
Image /page/2/Picture/3 description: The image shows a logo with the letters 'CM' stacked on top of each other on the left side. To the right of the letters, the word 'CENDRES+' is written in all caps on the top line. Below that, the word 'MÉTAUX' is written in all caps on the second line. The logo appears to be for a company that deals with ashes and metals.
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Traditional 510(k) – SFI-Bar® 510(k) Summary
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May 23, 2013
Table 2 Substantial Equivalence Comparison to Predicate Devices:
| | SFI-Bar® | Predicate Devices | | Comparison/<br>Performance<br>"Predicate Devices" |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| 510(k) No. | Candidate | K083876,<br>K111390 | K071638,<br>K042429,<br>K073268,<br>K053152,<br>K073282 | |
| Propriety<br>Name | SFI-Bar® | SFI-Bar® | "BioHorizons<br>Tapered Internal<br>Implant System",<br>"The Prodigy<br>System™ Dental<br>Implants",<br>"BioHorizons<br>Single-stage<br>Implant",<br>"BioHorizons<br>Single-stage<br>Implant Systems",<br>"BioHorizons<br>Internal Implant<br>System" | |
| Model no or<br>System | 05001022,<br>05001021,<br>05001020,<br>05001019,<br>05001023,<br>05001027,<br>05001026,<br>05001025,<br>05001024,<br>05001028,<br>05001032,<br>05001031,<br>05001030,<br>05001029,<br>05001033 | 05000576,<br>05000577,<br>05000578,<br>05000579 | Tapered internal<br>Implants - bone<br>level,<br>$Ø$ 3.8 (y)./ 4.6 (g)<br>/ 5.8 (h).<br><br>Internal Implants -<br>bone.level,<br>$Ø$ 3.5 (y) / 4.0 (g)<br>/ 5.0 (b) / 6.0 (b).<br><br>Single- stage<br>Implants - tissue<br>level,<br>$Ø$ 3.5 (y) / 4.0<br>(y&g) / 5.0 (g&b) /<br>6.0 (b). | |
| Common<br>Name: | Abutment for<br>Endosseous Implant<br>(Dental) | Abutment for<br>Endosseous Implant<br>(Dental) | Endosseous dental<br>implant | |
| Manufacturer | Cendres + Métaux<br>SA | Cendres + Métaux SA | BioHorizons<br>Implant Systems,<br>Inc. | |
| Product<br>Codes | NHA | NHA | DZE | Both SFI-Bar®s<br>are within the<br>same product |
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May 23, 2013
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Image /page/3/Picture/3 description: The image shows a logo with the letters "CM" on the left and the words "CENDRES+" and "MÉTAUX" on the right. The letters "CM" are in a bold, stylized font, and the words "CENDRES+" and "MÉTAUX" are in a smaller, sans-serif font. The logo is black and white. The plus sign is located to the right of the word "CENDRES".
Traditional 510(k) – SFI-Bar® 510(k) Summary
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May 23, 2013
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| | SFI-Bar® | Predicate Devices | | Comparison/<br>Performance<br>"Predicate Devices" |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | Candidate | K083876,<br>K111390 | K071638,<br>K042429.<br>K073268.<br>K053152.<br>K073282 | |
| | | | | code. All predicate<br>devices are within<br>a dental<br>application. |
| Regulation<br>Indicated<br>use | 872.3630<br>Intended to be used<br>with the implant<br>manufacturer's<br>implant (Table 1) to<br>provide support for<br>fixation of<br>overdentures. | 872.3630<br>Intended to be used<br>with the implant<br>manufacturer's<br>implant (Table 1:<br>SPI® Element<br>Platform 4.0 mm<br>implant) to provide<br>support for fixation of<br>overdentures. | 872.3640<br>Dental implant | Equivalent to<br>SFI-Bar® |
| Manu-<br>facturing<br>Process | Machined. Surface<br>treated (anodized). | Machined. | Machined. Surface<br>treated (anodized). | All SFI-Bar®<br>Implant adapter are<br>machined. The<br>new devices within<br>this submission are<br>also partially<br>anodized. The<br>anodization<br>process has no<br>influence on the<br>safety &<br>effectiveness of the<br>device. Therefore,<br>it can be stated<br>that the<br>manufacturing<br>process is<br>equivalent to the<br>SFI-Bar®<br>(predicate devices).<br>Equivalent to<br>SFI-Bar®<br>BioHorizons<br>implants are also<br>surface treated<br>(same color |
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Traditional 510(k) Submission USA: SFI-Bar® Format: Based on STED (GHTF/SG1/N011:2008) ·
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May 23, 2013
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Traditional 510(k) - SFI-Bar® 510(k) Summary
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May 23, 2013
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| | SFI-Bar® | Predicate Devices | | Comparison/<br>Performance<br>"Predicate Devices" |
|-----------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------|
| 510(k) No. | Candidate | K083876,<br>K1.11390 | K071638,<br>K042429,<br>K073268,<br>K053152,<br>K073282 | |
| Operating<br>Principle /<br>Basic<br>Design | Impression taking:<br>Optional,<br>preassembled (plug-<br>in connection). | Impression taking:<br>Optional,<br>preassembled (plug-in<br>connection). | Not relevant | ≒ Equivalent to<br>SFI-Bar® |
| | Abutment implant<br>connection: Screw<br>fixation. | Abutment implant<br>connection: Screw<br>fixation. | | |
| | Connecting principle<br>to overdenture:<br>Retentive system. | Connecting principle<br>to overdenture:<br>Retentive system. | | |
| | Cleaning procedures<br>for patient: Common<br>procedure for oral<br>hygiene. | Cleaning procedures<br>for patient: Common<br>procedure for oral<br>hygiene. | | |
| | Patient handling:<br>Common cleaning<br>and insertion of<br>prosthesis. | Patient handling:<br>Common cleaning and<br>insertion of denture. | | |
| Materials<br>incorporated<br>into key<br>functional<br>elements | Titanium | Titanium | Not relevant | ≒ Equivalent to<br>SFI-Bar® |
| Shelf Life | 95% after 10 years | 95% after 10 years | Not known by<br>Cendres + Métaux<br>SA | ≒ Equivalent to<br>SFI-Bar® |
| Packaging<br>and<br>sterilization | Dentalblister, non-<br>sterile. | Dentalblister, non-<br>sterile.<br>Tubular bag, non-<br>sterile | Not relevant | ≒ Equivalent to<br>SFI-Bar® |
Pertormance Data:
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Torque tests, application lesting and lunctional lesting have been conducted to evaluate the performance characteristics of the additional SFI-Rarib. The test methods used were the same as in the predicate device. Testing has shown that the SFI-BarQi is equivalent in performance characteristics to the predicate SFI-Bair®. The acceptance culeria were met.
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### CONFIDENTIAL
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May 23, 2013
Image /page/5/Picture/3 description: The image shows a logo with the text "CENDRES+" on the top line and "MÉTAUX" on the bottom line. To the left of the text is a stylized symbol that appears to be a combination of the letters 'C' and 'M'. The text and symbol are in black, and the background is white. The logo is simple and clean, with a focus on the text.
#### Traditional 510{k} - SFI-Bar® 510(k) Summary
May 23, 2013
Summary of Testing to Oernonstrate 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 identity worst-case test samples. Faligue lesting was not done as the basic cesign is the same than the predicate device. The evaluation was based on FDA guidance "Class II Soccial Controls Guidance Document: Root form Endosseous Dental Implants and Endosseous Dental Implant Abutments." Torque tests, application and functional tests have been carried out.
The summary of technological characteristics as well as the torque test, application and functional testing indicate that the cevice is safe and . effective for its intended use and performis as well or better than the predicate devices.
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### DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
September 23, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Cendres & Metaux SA Ms. Tanja Bongni Regulatory Affairs Manager Rue De Boujean 122 2501 Biel/Bienne, Switzerland
Re: K131526
Trade/Device Name: SFI-Bar® Regulation Number: 21 CFR 872.3630 Regulation Name: Endosscous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 11, 2013 Received: September 13, 2013
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 cnactment 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 cither 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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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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicallDevices/Safets/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,
Richard C. Chapman 2013.09.23 13:19:52 -04'00'
for
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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May 23, 2013
# Indications for Use
KISIS26 5 10(k) Number (if known):
Device Name:
SFI-Bark
Indications for Use:
The SFI-Bans is intended to be used with the implant translations in the called in to provide support ler lixation of overdentures.
Only the imp ant systems listed in Table I may be used will SFI-Mar-y.
The compatible implant systems are specified in Table . below
| Implant Manufacturer | 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 mm /<br>Regular Neck (RN) 4.8 mm |
| Thommen Medica | SPI Element Platform | 4.0 mm |
| Neoss | Neoss ProActive Implant | 3.5 / 4.0 / 4.5 / 5.0 / 5.5 mm |
| BioHorizons | Tapered Internal Implant - bone level | ⌀ 3.5 mm, ⌀ 4.5 mm, ⌀ 5.7 mm |
| | Internal Implants - bone level | |
| | Single-stage Implants - tissue level | |
Table I Compatible Implani Systems
AND / OR Prescription Jsc × (Pari 21 CFR 801 Subpart D)
Over-The-Counter Jsc (2) CFR 801 Subpart C)
(PLEASE DO NOT WRITE RELOW THIS : INE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CORH. Office of Device Evaluation (OOE)
Andrew I. Steen -S 2013.09.23 08:00:13 -04'00'
:Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Fage : ci l
K131524 510(k) Number:
