The following data is part of a premarket notification filed by Dmp Ltd with the FDA for Bright Restorative Materials.
| Device ID | K121915 |
| 510k Number | K121915 |
| Device Name: | BRIGHT RESTORATIVE MATERIALS |
| Classification | Material, Tooth Shade, Resin |
| Applicant | DMP LTD KALYVION AVENUE MARKOPOULO INDUSTRIAL ZONE Markopoulo, Attiki, GR 19003 |
| Contact | Dimitris Prantsidis |
| Correspondent | Dimitris Prantsidis DMP LTD KALYVION AVENUE MARKOPOULO INDUSTRIAL ZONE Markopoulo, Attiki, GR 19003 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-02 |
| Decision Date | 2012-09-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840326421229 | K121915 | 000 |
| 10840326421212 | K121915 | 000 |
| 10840326421205 | K121915 | 000 |
| 10840326421199 | K121915 | 000 |