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Dental Implants and Abutments

by Ditron Precision, Ltd. 510(k)

Active United States

510(k) K161497

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK161497 Date28 Oct 2016ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 23 Sep 2026

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

Dental Implants and Abutments are devices used in dental procedures to support prosthetic teeth. They are designed to be implanted into the jawbone to provide a stable foundation for crowns, bridges, or dentures.

These devices are supplied by Ditron Precision, Ltd. and have received FDA 510(k) clearance under K161497. They are intended for use in dental settings and are subject to regulatory review as substantially equivalent to legally marketed devices.

Other devices from Ditron Precision, Ltd.