ADH19— 510(k) K192961

Substantially Equivalent

3M Deutschland GmbH

FDA 510(k) clearance K192961 for ADH19, Substantially Equivalent on 2019-10-31. Applicant: 3M Deutschland GmbH. Device class: 2.

Clearance details

Applicant: 3M Deutschland GmbH
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2019-10-22
Decision date: 2019-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seefeld, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLE

K260485 — Any-Etch2026-05-14
K260430 — Porcelain Etch Gel2026-04-10
K252450 — Adhese 22026-03-05
K260682 — Bond-PR Universal Adhesive2026-03-03
K251587 — VITA VMLC Primer2026-02-23

More clearances from 3M Deutschland GmbH

K220257 — Permadyne2022-02-01
K192992 — Suglue 32019-11-05
K173318 — Rapid HB, Rapid LB, Rapid MB2017-10-31
K161922 — XP2022016-09-01
K153174 — Ketac Universal Aplicap2016-04-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.