The following data is part of a premarket notification filed by S&c Polymer Silicon- Und Composite Spezialitäten Gmbh with the FDA for Uniprime A, Uniprime E, Uniprime E/c.
| Device ID | K221033 |
| 510k Number | K221033 |
| Device Name: | UniPrime A, UniPrime E, UniPrime E/C |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | S&C Polymer Silicon- Und Composite Spezialitäten GmbH Robert-Bosch-Str. 2 Elmshorn, DE 25335 |
| Contact | Christian Böttcher |
| Correspondent | Christian Böttcher S&C Polymer Silicon- Und Composite Spezialitäten GmbH Robert-Bosch-Str. 2 Elmshorn, DE 25335 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-07 |
| Decision Date | 2022-07-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D745701198PVC00040 | K221033 | 000 |
| D745701198PVC00020 | K221033 | 000 |