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SFI-Bar

by Cendres & Metaux SA

510(k) K131526

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK131526 Date23 Sep 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NHA
Device Class
Class II
Regulation
21 CFR Part 872.3630
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SFI-Bar is an abutment bar designed for removable dentures on implants in edentulous upper and lower jaws. It provides tension‑free seating of the prosthesis on multiple implants, allowing the denture to be supported securely across the implant platform.

The device is supplied as a prefabricated component that can be adapted intra‑operatively by the dentist to the patient’s mouth, eliminating the risk of aspiration. It was cleared through the FDA 510(k) traditional pathway (decision description: Substantially Equivalent, product code NHA) and is identified by K‑number K131526.

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the SFI-Bar used for?

    The SFI-Bar is an abutment bar designed for removable dentures on implants in edentulous upper and lower jaws. It provides tension-free seating of the prosthesis on multiple implants, allowing the denture to be supported securely across the implant platform.

  • How is the SFI-Bar supplied and can it be customized?

    The device is supplied as a prefabricated component that can be adapted intra-operatively by the dentist to the patient's mouth, eliminating the risk of aspiration. This customization allows for a precise fit for each individual patient.

  • What is the regulatory status of the SFI-Bar?

    The SFI-Bar was cleared through the FDA 510(k) traditional pathway with a decision description of 'Substantially Equivalent' and is identified by K-number K131526. It is classified under product code NHA and was reviewed by the Dental advisory committee.

  • Is the SFI-Bar reusable or single-use?

    The device is designed to be adapted intra-operatively by the dentist to the patient's specific needs. While the description doesn't explicitly state whether it's single-use or reusable, the prefabricated nature and intra-operative adaptation suggest it may be intended for single clinical use.