The following data is part of a premarket notification filed by Innovation Meditech Gmbh with the FDA for Vita Enamic Stains.
| Device ID | K123761 |
| 510k Number | K123761 |
| Device Name: | VITA ENAMIC STAINS |
| Classification | Coating, Filling Material, Resin |
| Applicant | INNOVATION MEDITECH GMBH 3150 E. BIRCH ST. Brea, CA 92821 |
| Contact | Elizabeth Wolfsen |
| Correspondent | Elizabeth Wolfsen INNOVATION MEDITECH GMBH 3150 E. BIRCH ST. Brea, CA 92821 |
| Product Code | EBD |
| CFR Regulation Number | 872.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-07 |
| Decision Date | 2013-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E239M7001261 | K123761 | 000 |
| E239M7001251 | K123761 | 000 |
| E239M7001241 | K123761 | 000 |
| E239M7001231 | K123761 | 000 |
| E239M7001221 | K123761 | 000 |
| E239M7001211 | K123761 | 000 |
| E239M700111 | K123761 | 000 |
| E239M700101 | K123761 | 000 |