SFI-ANCHOR
Device Facts
| Record ID | K130618 |
|---|---|
| Device Name | SFI-ANCHOR |
| Applicant | Cendres & Metaux SA |
| Product Code | NHA · Dental |
| Decision Date | Mar 3, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3630 |
| Device Class | Class 2 |
Indications for Use
The SFI-Anchor® D20 is intended for the fixation of (dental) prostheses to corresponding dental implants. The compatible implant systems are specified in Table 1 below. The SFI-Anchor® CD20 is intended as an additional retaining element on CAD / CAM milled dental bars.
Device Story
SFI-Anchor D20/CD20 are endosseous dental implant abutments/bar attachments. D20 connects to Straumann dental implants via mating screw thread; CD20 screws onto CAD/CAM dental bars. Housing is cemented into dental prostheses; retention inserts provide retention-grip connection. Used in dental clinics by dentists/prosthodontists. Housing and inserts allow up to 10° divergence per implant (20° between two implants). Provides mechanical fixation of prostheses to implants or bars, improving stability and retention for patients requiring dental restorations.
Clinical Evidence
Bench testing only. No clinical data. Testing included analysis of platforms to identify worst-case samples, retention force testing, and simulated use testing. Evaluation performed in accordance with FDA guidance 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments'.
Technological Characteristics
Materials: Titanium alloy (ASTM F-136), Elitor® (ISO 22674), Pekkton® (ASTM D3418, D638, D790). Straight abutment/bar attachment form factor. Mechanical retention-grip principle. Divergence compensation up to 10° per implant. Non-software device.
Indications for Use
Indicated for fixation of dental prostheses to specific Straumann dental implants or as a retaining element on CAD/CAM dental bars. No specific age or gender restrictions; contraindications not explicitly listed.
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® (K111390, K102382, K083876)
- Locator Implant Anchor (K994257)
- P.004 RC/NC Bar and Bridge Abutments Line (K080239)
Submission Summary (Full Text)
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510(k) Summary: SFI-Anchor® D20, SFI-Anchor® CD20 510(k) no K130618
MAR February 24.0264
## 510(k) Summary
| Applicant's Name and Address | | | |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------|--|--|
| Submitter: | Cendres+Métaux SA<br>Rue de Boujean 122<br>2501 Biel/Bienne, Switzerland<br>Phone: +41 58 360 20 00<br>Fax: +41 58 360 20 10 | | |
| Contact Person: | Tanja Bongni<br>Regulatory Affairs Manager | | |
| Date of Submission: | February 24, 2014 | | |
| Name of the Device | | | |
| Trade Names: | SFI-Anchor® D20, SFI-Anchor® CD20 | | |
| Common Name: | Abutment, implant, Dental, Endosseous | | |
| Classification Name: | Endosseous dental implant abutment | | |
| Regulation Number: | 21 CFR 872.3630 | | |
| Product Code: | NHA | | |
| Device Class: | II | | |
| | | | |
Legally Marketed Device to which Equivalence is Claimed (Predicate Device)
| Trade Name | 510(k) no |
|-------------------------------------------|---------------------------|
| SFI-Bar® | K111390, K102382, K083876 |
| Locator Implant Anchor | K994257 |
| P.004 RC/NC Bar and Bridge Abutments Line | K080239 |
Figure 1 Predicate Devices
### Description of the Device
#### Device Description:
The SFI-Anchor® D20 is an endosseous dental implant abutment for the fixation of (dental) prostheses to the following ITI Dental Implant System® / Straumann® Dental Implant Systems:
Standard Ø 4.1 mm Regular Neck (RN) / Standard Ø 4.8 mm Regular Neck (RN) / Standard Plus Ø 4.1 mm Regular Neck (RN) / Standard Plus Ø 4.8 mm Regular Neck (RN) / Tapered Effect Ø 4.1 mm Regular Neck (RN) / Bone Level Ø 4.1 mm, Regular CrossFit® (RC) / Bone Level Ø 4.8 mm, Regular CrossFit® (RC).
The SFI-Anchor® CD 20 is intended as an additional retaining element on dental bars. The SFI-Anchor® D20 are straight abutments with gingival heights ranging from 1mm to 5 mm. The SFI-Anchor® CD 20 is a straight bar attachment. The SFI-Anchor® Housing and the SFI-Anchor® Retention Inserts can correct for up to 10° of divergence (20° of divergence between two implants).
The SFI-Anchor® is offered in a diameter 4.8 mm. The SFI-Anchor® D20 is connected to the corresponding implants via a mating screw thread and interface geometry. The SFI-Anchor® CD20 is directly screwed on a dental bar construct. The SFI-Anchor® Housing is cemented in the dental prostheses. The SFI-Anchor® Housing, along with an SFI-Anchor® Retention Insert, allow connection of the prosthesis to the abutment / bar attachment by retention-grip.
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Image /page/1/Picture/0 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 letter "C" that is thicker than the text. The text is in a sans-serif font and is black. The logo is simple and modern.
510(k) Summary: SFI-Anchor® D20, SFI-Anchor® CD20 510(k) no K130618
The abutments / bar attachment are machined from Titanium Alloy conforming to ASTM F-136. Other SFI-Anchor® key functional parts are made out of Elitor® (conforming to standard ISO 22674) and of Pekkton® conforming to standard ASTM D3418, ASTM D638 and ASTM D790.
Indications for Use:
The SFI-Anchor® D20 is intended for the fixation of (dental) prostheses to corresponding dental implants.
The compatible implant systems are specified in Table 1 below.
| Implant Manufacturer: Institut Straumann | |
|------------------------------------------------------------------------------------------|----------------------------------------------|
| Implant System: ITI Dental Implant System® respectively Straumann® Dental Implant System | |
| Implant line name(s): see below | |
| -Standard Ø 4.1 mm Regular Neck (RN) | -Standard Ø 4.8 mm Regular Neck (RN) |
| -Standard Plus Ø 4.1 mm Regular Neck (RN) | -Standard Plus Ø 4.8 mm Regular Neck (RN) |
| -Tapered Effect Ø 4.1 mm Regular Neck (RN) | -Bone Level Ø 4.1 mm, Regular CrossFit® (RC) |
| -Bone Level Ø 4.8 mm, Regular CrossFit® (RC) | |
Table 1 Compatible Implant Systems
The SFI-Anchor® CD20 is intended as an additional retaining element on CAD / CAM milled dental bars.
#### Summary Technological Characteristics
The following Figure 2 describes similarities and differences between the subject devices and legally cleared predicates:
| | Candidates: | | Predicate Devices | | | Comparison |
|---------------------------------------------------------------------|----------------------------------------------------------------------|------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------|-----------------------------------------------------------------|
| | SFI-Anchor®<br>D20 | SFI-Anchor®<br>CD20 | SFI-Bar® | Locator<br>Implant<br>Anchor | P.004<br>RC/NC Bar<br>and Bridge<br>Abutments<br>Line | |
| Platform<br>compatibility<br>(implant) | Refer to<br>Table 1 | N/A | Regular Neck<br>(RN)<br>(and others) | --- | Regular<br>CrossFit®<br>(RC) (and<br>others) | Same<br>implant<br>platforms<br>than SFI-<br>Bar® and<br>P.004. |
| Basic Design<br>of the<br>Abutment /<br>Element | Straight,<br>gingival<br>heights<br>ranging from<br>1 mm to 5<br>mm. | Straight | Straight,<br>gingival<br>heights<br>ranging from<br>1 to 6. | Straight,<br>gingival<br>heights<br>ranging from<br>1 to 5. | Straight (and<br>others) | Comparable<br>to<br>Predicates |
| Retentive<br>force | Up to 17.5 N | Up to 17.5 N | Up to 14 N | Up to 5.0<br>pounds<br>(22.25 N) | | Comparable<br>to SFI-<br>Bar® and<br>Locator. |
| Divergence<br>Compensation<br>by Housing<br>and Retention<br>insert | Up to 10° per<br>implant<br>(20° between<br>2 implants) | Up to 10°<br>per implant<br>(20°<br>between 2<br>implants) | | | | |
Figure 2 Comparison with Predicate Devices
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Image /page/2/Picture/0 description: The image contains a logo with the text "CENDRES+ METAUX" to the right of a stylized letter "C". The text is stacked, with "CENDRES+" on top and "METAUX" below. The letter "C" is bold and stylized, with a curved shape. The overall design is simple and modern.
510(k) Summary: SFI-Anchor® D20, SFI-Anchor® CD20 510(k) no K130618
The following materials with permanent patient contact are incorporated into key functional elements: Titanium; Elitor®; Pekkton® (blue, red, yellow, green). Similar material was used in the legally marketed predicate devices.
The proposed devices are similar in terms of design, angulations for use and incorporate the same technological characteristics as the predicate devices.
In order to assure safety of the SFI-Anchor® a failure mode, effect and criticality analysis has been performed.
#### Non-Clinical Performance Data
The specifications for a reliable connection between the dental implant and the SFI-Anchor® are developed in close cooperation with the dental implant manufacturer. To ensure compatibility today and in future there is a Quality Agreement between Cendres + Métaux SA and the Institut Straumann AG in place. This Quality Agreement handles among other things the Design Control process and Vigilance. 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. Retention force testing and simulated use testing were done. Furthermore, the evaluation was based on FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
#### Conclusion as to Substantial Equivalence
Based on the comparison of the indications for use, the technological characteristics and the non-clinical testing it can be concluded that the SFI-Anchor® is substantially equivalent to the predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the eagle in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W066-G609 Silver Spring, MD 20993-0002
March 3, 2014
Cendres+Metaux SA Ms. Tanja Bongni Regulatory Affairs Manager Rue de Boujean 122 2501 Biel/Bienne SWITZERLAND
Re: K130618
Trade/Device Name: SFI-Anchor® D20, SFI-Anchor® CD20 S Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: January 29, 2014 Received: January 30, 2014
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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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 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.fda.goy/MedicalDevices/Resourcesfor You/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/MedicalDevices/Safety/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Image /page/4/Picture/7 description: The image shows the text "Erin" followed by a complex, maze-like design that incorporates the letters "F", "D", "K", "A", and "h". The text "-S" is located to the right of the maze-like design. The overall image appears to be a logo or a stylized wordmark.
Erin I. Keith, M.S. Acting 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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# Indications for Use
510(k) Number (if known):
K130618
Device Names:
SFI-Anchor® D20, SFI-Anchor® CD 20
Indications for Use:
The SFI-Anchor® D20 is intended for the fixation of (dental) prostheses to corresponding dental implants.
The compatible implant systems are specified in Table 1 below.
| Implant Manufacturer: Institut Straumann | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Implant System: ITI Dental Implant System® respectively Straumann® Dental Implant System | |
| Implant line name(s): see below | |
| -Standard Ø 4.1 mm Regular Neck (RN)<br>-Standard Plus Ø 4.1 mm Regular Neck (RN)<br>-Tapered Effect Ø 4.1 mm Regular Neck (RN)<br>-Bone Level Ø 4.8 mm, Regular CrossFit® (RC) | -Standard Ø 4.8 mm Regular Neck (RN)<br>-Standard Plus Ø 4.8 mm Regular Neck (RN)<br>-Bone Level Ø 4.1 mm, Regular CrossFit® (RC) |
Table 1 Compatible Implant Systems
The SFI-Anchor® CD20 is intended as an additional retaining element on CAD / CAM milled dental bars.
Prescription Use X (Part 21 CFR 801 Subpart D) AND / OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary S. Runner -S
SR DOSNA 2014.02.28
11:09:55:05'00'
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