The following data is part of a premarket notification filed by Dmp Ltd with the FDA for Nanoceram- Bright.
| Device ID | K102257 |
| 510k Number | K102257 |
| Device Name: | NANOCERAM- BRIGHT |
| 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 | 2010-08-10 |
| Decision Date | 2010-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840326421182 | K102257 | 000 |
| 00840326421031 | K102257 | 000 |
| 10840326421045 | K102257 | 000 |
| 00840326421055 | K102257 | 000 |
| 10840326421069 | K102257 | 000 |
| 10840326421076 | K102257 | 000 |
| 10840326421083 | K102257 | 000 |
| 10840326421090 | K102257 | 000 |
| 10840326421106 | K102257 | 000 |
| 10840326421113 | K102257 | 000 |
| 10840326421120 | K102257 | 000 |
| 10840326421137 | K102257 | 000 |
| 10840326421144 | K102257 | 000 |
| 10840326421151 | K102257 | 000 |
| 10840326421168 | K102257 | 000 |
| 10840326421175 | K102257 | 000 |
| 10840326421021 | K102257 | 000 |