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Lew Prosthetic Locking Device

by Howmedica Corp. 510(k)

Active United States

510(k) K770131

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK770131 Date28 Jan 1977ClearedStatusActive

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  • Withdrawn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
DZL
Device Class
Class II
Regulation
21 CFR Part 872.4880
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Lew Prosthetic Locking Device is an intraosseous fixation screw. It is designed to function as a prosthetic locking component within dental applications.

This device is manufactured by Howmedica Corp. and received FDA 510(k) clearance under the number K770131. It is classified as a Class II medical device under regulation number 872.4880.

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