The following data is part of a premarket notification filed by S&c Polymer Silicon- Und Composite Spezialitaeten Gmbh with the FDA for Lc Glossfill Xr.
| Device ID | K182778 |
| 510k Number | K182778 |
| Device Name: | LC GLOSSFILL XR |
| 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 | 2019-04-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6620712583910 | K182778 | 000 |
| D6620712583830 | K182778 | 000 |
| D6620712583750 | K182778 | 000 |
| D6620712583590 | K182778 | 000 |