Skip to content

Branemark System 4.00 Mm Fixture

by Nobelpharma USA, Inc. 510(k)

Active United States

510(k) K925764

Overview

The BRANEMARK SYSTEM 4.00 MM FIXTURE is a third-party compatible implant system for the treatment of periodontal defects in patients with complete edentulous arches, particularly those undergoing surgical extraction of teeth due to severe bone loss and inadequate attachment support.

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK925764 Date5 Oct 1993ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

Other devices from Nobelpharma USA, Inc.

See all devices from Nobelpharma USA, Inc. →