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SFI-ANCHOR

by Cendres & Metaux SA

510(k) K130618

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 NumberK130618 Date3 Mar 2014ClearedStatusActive

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  • Withdrawn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, 6 Oct 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-ANCHOR is a dental device designed as a cross-piece, supporting bar, or attachment for dental prostheses, including parts for these goods. It is intended for use in dental prosthetic applications to provide retention and support.

The device is supplied as a reusable component for dental prostheses and is authorized under FDA 510(k) clearance (K130618) with product code NHA. It is manufactured by Cendres & Metaux SA and distributed via Straumann, with no indication of sterility, single-use status, MRI safety, or specific storage requirements in the provided data.

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See all devices from Cendres & Metaux SA →

Questions

AI-generated answers, 6 Oct 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-ANCHOR used for in dental applications?

    The SFI-ANCHOR is designed as a cross-piece, supporting bar, or attachment for dental prostheses to provide retention and support in dental prosthetic applications, as it is intended for use in supporting dental prosthetic goods.

  • Is the SFI-ANCHOR a single-use or reusable device?

    The SFI-ANCHOR is supplied as a reusable component for dental prostheses, meaning it is intended for multiple uses after appropriate cleaning and reprocessing, not as a single-use disposable item.

  • How is the SFI-ANCHOR supplied and distributed?

    The SFI-ANCHOR is manufactured by Cendres & Metaux SA and distributed via Straumann, with no indication of sterility or specific storage requirements provided in the device data.