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Branemark Radiographic Depth Guage

by Nobelpharma USA, Inc.

510(k) K953435

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 NumberK953435 Date3 Oct 1995ClearedStatusActive

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  • Withdrawn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, 27 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 Radiographic Depth Gauge is a dental device used to assist in the assessment of bone dimensions during surgical procedures. It functions as a diagnostic tool to help clinicians confirm available bone and identify anatomical landmarks when planning for dental implants.

This device is supplied by Nobelpharma USA, Inc. and has received FDA 510(k) clearance. It is intended to be used in conjunction with conventional diagnostic methods, such as radiographic imaging and probing, to ensure accurate measurements during the surgical process.

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Questions

AI-generated answers, 27 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 primary purpose of the Branemark Radiographic Depth Gauge?

    This device is designed to assist clinicians in assessing bone dimensions and identifying anatomical landmarks during dental implant surgical procedures. It serves as a diagnostic aid to confirm available bone when planning for implants.

  • How should this device be used in a clinical setting?

    The gauge is intended to be used in conjunction with conventional diagnostic methods, such as probing and radiographic imaging. It provides a physical reference to ensure accurate measurements are taken during the surgical process.

  • What is the regulatory status of this device?

    The Branemark Radiographic Depth Gauge has received FDA 510(k) clearance under the submission number K953435. It was determined to be substantially equivalent to existing devices within the dental product category.