The following data is part of a premarket notification filed by Dmg Chemisch-pharmazeutische Fabrik Gmbh with the FDA for Luxacrown, Shade A1, A2, A3, A3.5; Luxacrown B1, B3, C2, D2.
| Device ID | K183337 |
| 510k Number | K183337 |
| Device Name: | LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2 |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | DMG Chemisch-Pharmazeutische Fabrik GmbH Elbgaustrasse 248 Hamburg, DE 22547 |
| Contact | Sonja Toeppen |
| Correspondent | Pamela Papineau Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-03 |
| Decision Date | 2019-05-29 |