The following data is part of a premarket notification filed by Dmg Usa, Inc. with the FDA for Luxatemp/luxatemp Solar/instatemp.
| Device ID | K013674 |
| 510k Number | K013674 |
| Device Name: | LUXATEMP/LUXATEMP SOLAR/INSTATEMP |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-07 |
| Decision Date | 2002-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D813SPD13200 | K013674 | 000 |
| EDMG1105878 | K013674 | 000 |
| EDMG1105868 | K013674 | 000 |
| EDMG1105858 | K013674 | 000 |
| EDMG1104061 | K013674 | 000 |
| EDMG1104048 | K013674 | 000 |
| EDMG1104038 | K013674 | 000 |
| EDMG1104028 | K013674 | 000 |
| EDMG1104018 | K013674 | 000 |
| EDMG1104001 | K013674 | 000 |
| EDMG1103688 | K013674 | 000 |
| EDMG1103608 | K013674 | 000 |
| 00841549115998 | K013674 | 000 |
| EDMG1105888 | K013674 | 000 |
| EDMG1105898 | K013674 | 000 |
| EDMG1107108 | K013674 | 000 |
| D813SPD13030 | K013674 | 000 |
| D813SPD13020 | K013674 | 000 |
| D813SPD13010 | K013674 | 000 |
| D813SPD13000 | K013674 | 000 |
| D813CR10430 | K013674 | 000 |
| D813CR10420 | K013674 | 000 |
| D813CR10410 | K013674 | 000 |
| D813CR10400 | K013674 | 000 |
| D813CR10390 | K013674 | 000 |
| EDMG1107230 | K013674 | 000 |
| EDMG1107221 | K013674 | 000 |
| EDMG1107191 | K013674 | 000 |
| 00841549100383 | K013674 | 000 |