Who can help prepare an FDA 510(k) submission like 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..?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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..

Q: Who is the manufacturer of 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..?

Cendres & Metaux SA filed the 510(k) submission for 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.. (K111390).

Q: What is the FDA product code for 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..?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

Q: What is the regulatory pathway for 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..?

510(k) clearance (submission type: Special).

Q: What are the predicate devices for 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..?

SFI-Bar® (K083876); SFI-Bar® (K102382); RN synOcta® (K073628).

K111390 · Cendres & Metaux SA · NHA · Sep 12, 2011 · Dental

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
Attributes	Therapeutic

Intended 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

SFI-Bar® (K083876)
SFI-Bar® (K102382)
RN synOcta® (K073628)

Related Devices

K102382 — SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT · Cendres & Metaux SA · Dec 3, 2010
K131526 — SFI-BAR · Cendres & Metaux SA · Sep 23, 2013
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

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/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 and the letter "C" are in black and the background is white. #### 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. {1}------------------------------------------------ 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 is in a sans-serif font and is black. The logo appears to be for a company that deals with ashes and metals. 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 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 | ### 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. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a logo for Cendres+ Metaux. The logo consists of a stylized letter "M" on the left, followed by the words "CENDRES+" on the top line and "METAUX" on the bottom line. The text is in a simple, sans-serif font and is all in black. ・・ · - K11.1390 . : . : : TABLE B summarizes the substantial equivalence comparison to the predicate device: | TABLE B Substantial Equivalence Comparison to Predicate Devices: | | | |------------------------------------------------------------------|--|--| | | | | . | Attribute | Candidates | Predicate Device | Predicate Device | |---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | SFI-BarⓇ | SFI-BarⓇ K083876, K102382 | RN synOctaⓇ 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 System®: Standard Ø 4.1 mm and Ø 4.8 mm / Standard Plus Ø 4.1 mm and Ø 4.8 mm/ Tapered Effect Ø 4.1 mm and Ø 4.8 mm / Regular Neck (RN) Ø 4.8 mm | ITI Dental Implant System®: Standard Ø 4.1 mm and Ø 4.8 mm / Standard Plus Ø 4.1 mm and Ø 4.8 mm/ Tapered Effect Ø 4.1 mm and Ø 4.8 mm/ Regular Neck (RN) Ø 4.8 mm | ITI Dental Implant System®: Standard Ø 4.8 mm RN and Ø 6.5 mm WN / Standard Plus Ø 4.8 mm and Ø 6.5 mm WN/ Tapered Effect Ø 4.8 mm and Ø 6.5 mm WN | | | Neoss ProActive Implant: Ø 3.5 / 4.0 / 4.5 / 5.0 / 5.5 mm | 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 | 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 | Titanium abutment, Ceramicor sleeve | | Manufacturer | CENDRES+METAUX SA | CENDRES+METAUX SA | Institut Straumann AG | | Indication for Use | The SFI-Bar® is intended to be used with the implant manufacturer's (see TABLE A) implant to provide support for fixation of overdentures. | The SFI-Bar® is intended to be used with the implant manufacturer's (see TABLE A) implant to provide support for fixation of overdentures. | Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and 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 primary splinting of implants. Countering forces that would dislodge the | 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 primary splinting of implants. Countering forces that would dislodge the | Impression taking: required. Abutment Implant connection: Screw fixation. Bar connection: soldered. Connecting principle to overdenture: retentive system. Bar fixation on implant: screwed. Countering forces that would dislodge the | | | | | | | Attribute | Candidates | Predicate Device | Predicate Device | | | denture, distribution of shear forces, resilience compensation. | denture, distribution of shear forces, resilience compensation. | 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. | Cleaning procedures for patient: common procedure for oral hygiene. | | | Patient handling: common cleaning and insertion of denture. | Patient handling: common cleaning and insertion of denture. | Patient handling: common cleaning and insertion of denture. | | Shelf life | 95% after 10 years | 95% after 10 years | 95% after 10 years | | Packaging, materials and processes | Produced on process orientated CNC machines. The last step is a validated cleaning process (same processes). | Produced on process orientated CNC machines. The last step is a validated cleaning process (same processes). | Produced on process oriented CNC machines. The last step is a validated cleaning process (same process). | | | Packaging: dental blister, non-sterile. | Packaging: dental blister, non-sterile. | Packaging: non-sterile. | | Abutment / implant adapter used in context with the immediate loading. | Yes (this submission). | No. | Yes. Abutment cleared for immediate loading. | {3}------------------------------------------------ Image /page/3/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 in a sans-serif font and is black. The logo appears to be for a company or organization named Cendres + Métaux. 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. {4}------------------------------------------------ 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 stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in capital letters. 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. {5}------------------------------------------------ ## 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 {6}------------------------------------------------ Image /page/6/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 simple, sans-serif font and is aligned to the right of the "C". 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 / Standard Plus 4.1 and 4.8 mm / Tapered Effect 4.1 and 4.8 / 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