Rapid HB, Rapid LB, Rapid MB— 510(k) K173318

Name: FDA 510(k) clearance K173318
Creator: U.S. Food and Drug Administration
Published: 2017-10-31

Substantially Equivalent

3M Deutschland GmbH

FDA 510(k) clearance K173318 for Rapid HB, Rapid LB, Rapid MB, Substantially Equivalent on 2017-10-31. Applicant: 3M Deutschland GmbH. Device class: 2.

Clearance details

Applicant: 3M Deutschland GmbH
Product code: Code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2017-10-20
Decision date: 2017-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seefeld, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code ELW

view all

K254112 — Dia-X Sil Bite2026-03-19
K253501 — Hydro Print Premium Fast Set - 454g (1lb) (052037) +9 more2025-10-31
K250969 — JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST2025-06-27
K241924 — Elastic Impression Material2024-12-27
K242360 — Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator2024-11-15

More clearances from 3M Deutschland GmbH

view all

K220257 — Permadyne2022-02-01
K192992 — Suglue 32019-11-05
K192961 — ADH192019-10-31
K161922 — XP2022016-09-01
K153174 — Ketac Universal Aplicap2016-04-13

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