The following data is part of a premarket notification filed by S&c Polymer Silicon- Und Composite Spezialitaeten Gmbh with the FDA for Xp Composite.
Device ID | K182780 |
510k Number | K182780 |
Device Name: | XP Composite |
Classification | Material, Tooth Shade, Resin |
Applicant | S&C Polymer Silicon- Und Composite Spezialitaeten GmbH Robert-Bosch-Str. 2 Elmshorn, DE 25335 |
Contact | Christian Boettcher |
Correspondent | Christian Boettcher S&C Polymer Silicon- Und Composite Spezialitaeten GmbH Robert-Bosch-Str. 2 Elmshorn, DE 25335 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-10-01 |
Decision Date | 2019-07-03 |