LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2— 510(k) K183337

Name: FDA 510(k) clearance K183337
Creator: U.S. Food and Drug Administration
Published: 2019-05-29

Substantially Equivalent

DMG Chemisch-Pharmazeutische Fabrik GmbH

FDA 510(k) clearance K183337 for LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2, Substantially Equivalent on 2019-05-29. Applicant: DMG Chemisch-Pharmazeutische Fabrik GmbH. Device class: 2.

Clearance details

Applicant: DMG Chemisch-Pharmazeutische Fabrik GmbH
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2018-12-03
Decision date: 2019-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamburg, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBG

view all

K261261 — Dura-Arch2026-04-17
K253380 — FLNT Base and FLNT Temp2026-03-02
K251271 — TempFIT Temporary Crown and Bridge Resin2025-06-23
K243370 — DentaTOOTH2025-05-05
K243621 — Evoblock, Perléon2025-04-22

More clearances from DMG Chemisch-Pharmazeutische Fabrik GmbH

view all

K213201 — DeltaFil, DeltaFil Conditioner2022-06-01
K991172 — IONOSIT BOND1999-05-17
K924830 — LUXATEMP AUTOMIX1994-04-29

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