The following data is part of a premarket notification filed by Dmg Usa, Inc. with the FDA for Luxatemp Ultra /star.
| Device ID | K101710 |
| 510k Number | K101710 |
| Device Name: | LUXATEMP ULTRA /STAR |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | DMG USA, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau DMG USA, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-17 |
| Decision Date | 2010-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EDMG1109118 | K101710 | 000 |
| EDMG1109108 | K101710 | 000 |
| EDMG1109098 | K101710 | 000 |
| EDMG1109088 | K101710 | 000 |
| EDMG1109078 | K101710 | 000 |
| EDMG1109068 | K101710 | 000 |
| EDMG1109051 | K101710 | 000 |
| EDMG1109041 | K101710 | 000 |
| EDMG1109011 | K101710 | 000 |