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 |