510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K941619Substantially Equivalent

Lorenz Surgical Threaded Dental Implant

Zimmer GmbH, Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941619 is the FDA 510(k) clearance record for LORENZ SURGICAL THREADED DENTAL IMPLANT, a class II device, cleared for Biomet, Inc. on under FDA product code DZE (Implant, Endosseous, Root-Form). FDA records list 872 510(k) clearances for ZIMMER GMBH, from to . As of , FDA records show no recalls naming K941619.

Clearance record

Decision date
Received
(178 days to decision)
Product code
DZE Implant, Endosseous, Root-Form
Regulation
21 CFR 872.3640
Device class
Class II
Review panel
Dental
Applicant
Biomet, Inc. Airport Industrial Park, Warsaw IN
510(k) summary
Summary
Third party review
No

Clearances, product code DZE

Trailing 12 months
19 clearances under product code DZE in the twelve months to November 2026, December 2025 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code DZE, trailing twelve months
MonthClearances
December 20254
January 20261
February 20262
March 20264
April 20260
May 20261
June 20264
July 20260
August 20261
September 20261
October 20261
November 20260