Predicate Devices

Reference Devices

None

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a mechanical dental device and does not mention any AI or ML components or capabilities.

Therapeutic

No
A therapeutic device is one that treats or prevents a disease or condition. This device is an implant accessory (a bar) that is primarily intended to provide support for the fixation of overdentures, which is a structural or restorative function, not a therapeutic one.

Diagnostic

No

Explanation: The device is a dental implant component (SFI-Bar®) used for the fixation of removable overdentures, not for diagnosing medical conditions. Its intended use is to provide mechanical support.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the SFI-Bar® consists of physical components: an implant adapter (abutment) and a stress-free bar. These are hardware components, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to provide support for fixation of overdentures, which is a mechanical function within the oral cavity.
Device Description: The device is described as a physical connection between dental implants and overdentures.
Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease, condition, or state of health. It does not analyze biological samples (blood, urine, tissue, etc.) or provide information for diagnostic purposes.
Performance Studies: The performance studies focus on mechanical properties like torque, application, and functional testing, not diagnostic accuracy or analytical performance.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (within the body) for a structural and mechanical purpose.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SFI-Bar® is intended to be used with the implant manufacturer's (Table 1) implant to provide support for fixation of overdentures.

Product codes

NHA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Oral Cavity

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Torque tests, application testing and functional testing have been conducted to evaluate the performance characteristics of the additional 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K083876

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
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.(b)
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.)

Summary

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Image /page/0/Picture/0 description: The image shows a logo with the text "CENDRES + MÉTAUX". To the left of the text is a stylized letter "C". The text is stacked, with "CENDRES +" on top and "MÉTAUX" on the bottom. The logo is black and white.

K102382

21.10.2010

DEC - 3 2010

510(k) Summary

Applicant's Name and Address

Submitter:

Contact Person:

October 21, 2010

Tanja Bongni

Phone: Fax:

Cendres+Métaux SA

Rue de Boujean 122

2501 Biel/Bienne, Switzerland

Consultant Regulatory Affairs

+41 58 360 20 00

+41 58 360 20 10

Date of Submission:

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) K083876 Predicate Device(s):

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.

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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 "M". The text and the letter are all in black. The logo appears to be for a company that deals with ashes and metals.

Intended Use of the Device:

The SFI-Bar® is intended to be used with the implant manufacturer's . (Table 1) implant to provide support for fixation of overdentures.

Table 1 Compatible Commercial Implant Manufacturers

Implant Company	Implant System	Implant Platform Diameter	Candidates
Thommen Medical	SPI® Element Platform	4.0 mm	SFI-Bar® Implant adapter
Straumann®
and
SFI-Bar® Implant adapter for
Neoss Implant	SFI-Bar® Implant adapter SPI®
Element PF Ø 4.0

Already cleared in combination
with the SFI-Bar®

Neoss ProActive Implant:
Ø 3.5 / 4.0 / 4.5 / 5.0 / 5.5 mm | Thommen Implant System:
SPI® Element Platform Ø 4.0 mm | | | |
| Device Material | Wrought Titanium-6Aluminium-
4Vanadium ELI Alloy for
Surgical Implant applications | Wrought Titanium-6Aluminium-
4Vanadium ELI Alloy for
Surgical Implant applications | | | |
| Indications for Use | The SFI-Bar® is intended to be
used with the implant
manufacturer's (Table 1)
implant to provide support for
fixation of overdentures: | The SFI-Bar® is intended to be
used with the SPI Element
Platform 4.0 mm implant to
provide support for fixation of
overdentures. | | | |
| Operating principle /
Basic Design | Impression taking: Optional,
preassembled (plug-in
connection).

Abutment implant connection:
Screw fixation.

Connecting principle to
overdenture: Retentive system.

Bar fixation on implant:
Screwed.

Function: Stabilization and | Impression taking: Optional,
preassembled (plug-in
connection).

Abutment implant connection:
Screw fixation.

Connecting principle to
overdenture: Retentive system.

Bar fixation on implant:
Screwed.

Function: Stabilization and | | | |

Summary Technological Characteristics:

Comparison /Compatibility Substantially Equivalence: 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.

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 1 , column "Implant Company").

There are Quality Agreements between Cendres + Métaux and the implant companies in place. Those agreements handle among 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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Image /page/2/Picture/0 description: The image shows a logo with the letters 'CM' on the left and the words 'CENDRES' and 'MÉTAUX' stacked on the right. The 'C' and 'M' are large and bold, with the 'M' slightly overlapping the 'C'. The word 'CENDRES' is above 'MÉTAUX', and there is a plus sign to the right of 'CENDRES'. The text is in a simple, sans-serif font.

・・ :

.

....

.

. . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

.

Table 2 Substantial Equivalence Comparison to Predicate Devices

:

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Image /page/3/Picture/0 description: The image shows a logo for a company called "CENDRES + MÉTAUX". The logo consists of a stylized letter "C" on the left, followed by the company name in a sans-serif font. The word "CENDRES" is on top of the word "MÉTAUX", and there is a plus sign after the word "CENDRES".

Special 510(k) - SFI-Bar® 510(k) Summary

Attribute	Candidates	Predicate Device
	primary splinting of implants.	primary splinting of implants.
	Countering forces that would
dislodge the denture,
distribution of shear forces,
resilience compensation.	Countering forces that would
dislodge the denture,
distribution of shear forces,
resilience compensation.
	Cleaning procedures for patient:
Common procedure for oral
hygiene.	Cleaning procedures for patient:
Common procedure for oral
hygiene.
	Patient handling:
Common cleaning and insertion	Patient handling:
Common cleaning and insertion
	of denture.	of denture.
Shelf life	95% after 10 years	95% after 10 years
Packaging, materials and
processes	Produced on process orientated
CNC machines. The last step is	Produced on process orientated
CNC machines. The last step is
	a validated cleaning process
(same processes).	a validated cleaning process
(same processes).
	Packaging: Dentalblister,
non-sterile.	Packaging: Dentalblister,
non-sterile.

Performance Data:

Summary of Testing to Demonstrate Safety and Effectiveness / Conclusion:

Torque tests, application testing and functional testing have been conducted to evaluate the performance characteristics of the additional 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.

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." 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 device is safe and effective for its intended use and performs as well or better than the predicate devices.

4

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol with three curved lines, which is the official symbol of the department.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Tanja Bongni Consultant Regulatory Affairs Cendres & Metaux SA Rue De Boujean 122 Biel/Bienne Switzerland 2501

DEC - 3 2010

Re: K102382

Trade/Device Name: SFI-Bar® Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 21, 2010 Received: November 5, 2010

Dear Mr. 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.

5

Page 2- Mr. 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/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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

h 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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Image /page/6/Picture/0 description: The image shows a logo with the letters 'CM' on the left and the words 'CENDRES' and 'MÉTAUX' on the right. The 'CM' is stylized with the 'C' wrapping around the 'M'. The word 'CENDRES' is above the word 'MÉTAUX'. The logo is black and white.

·

20.09.2010

Indications for Use Statement

510(k) Number:

K102382

Device Name:

SFI-Bar®

Indications for Use:

The SFI-Bar® is intended to be used with the implant manufacturer's (Table 1) implant to provide support for fixation of overdentures.

DEC

ന്ന
1

2010

612387

Table 1 Compatible Commercial Implant Manufacturers

| Implant Company | Implant System | Implant Platform
Diameter |
|--------------------|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Thommen Medical | SPI® Element
Platform . | 4.0 mm |
| Neoss | Neoss ProActive
Implant | 3.5 / 4.0 / 4.5 / 5.0 /
5.5 mm |
| Institut Straumann | ITI Dental Implant
System® | Standard 4.1 and 4.8
mm /
Standard Plus 4.1 and
4.8 mm /
Tapered Effect 4.1 and
4.8 mm /
Regular Neck (RN) 4.8
mm |

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Üff) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Prescription Use X OR 510(k) NumbeQver-The-Counter