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Branemark System Temporary Solutions

by Nobelpharma USA, Inc.

510(k) K925766

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 NumberK925766 Date2 Aug 1994ClearedStatusActive

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  • Withdrawn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
DZE
Device Class
Class II
Regulation
21 CFR Part 872.3640
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Branemark System Temporary Solutions is a dental implant system designed for temporary restoration in oral and maxillofacial surgery. It provides a transitional solution for patients awaiting definitive prosthetic treatment, ensuring stability and functionality during the healing phase of osseointegrated implants.

This system is intended for use in dental offices and oral surgery clinics, supplied as a sterile, single-use or reusable component set depending on the specific application. It is classified under FDA product code DZE and has received 510(k) clearance for dental use, with regulatory oversight under the Traditional 510(k) pathway. Storage and handling must comply with manufacturer guidelines to maintain sterility and performance.

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Questions

AI-generated answers, 19 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 Branemark System Temporary Solutions used for in clinical practice?

    The Branemark System Temporary Solutions is designed to provide a transitional dental restoration for patients undergoing oral or maxillofacial surgery. It offers stability and functionality during the healing phase of osseointegrated implants, serving as a bridge until definitive prosthetic treatment can be permanently placed. This is particularly useful in cases where immediate full restoration isn’t feasible.

  • Is the Branemark System Temporary Solutions intended for single-use or can components be reused?

    The system is supplied as either a sterile, single-use or reusable component set, depending on the specific application. The manufacturer’s guidelines must be followed to ensure proper handling and sterility, whether components are intended for one-time use or repeated use in clinical settings.

  • Where should the Branemark System Temporary Solutions be stored, and how does this affect its use?

    Storage must comply with the manufacturer’s instructions to preserve sterility and performance. Since the system is intended for use in dental offices and oral surgery clinics, proper storage conditions—such as temperature, humidity, and packaging integrity—are critical to maintaining its reliability for either single-use or reusable applications.

  • What regulatory pathway was followed for the FDA clearance of the Branemark System Temporary Solutions?

    The Branemark System Temporary Solutions received FDA clearance through the Traditional 510(k) pathway, specifically under product code DZE for dental devices. The clearance was granted in 1994 after a determination of substantial equivalence to a predicate device, with oversight by the Dental (DE) Advisory Committee.