The following data is part of a premarket notification filed by S&c Polymer Silicon- Und Composite Spezialitaten Gmbh with the FDA for Lc Resincal Pc.
| Device ID | K202413 |
| 510k Number | K202413 |
| Device Name: | LC ResinCal PC |
| Classification | Liner, Cavity, Calcium Hydroxide |
| Applicant | S&C Polymer Silicon- Und Composite Spezialitaten GmbH Robert-Bosch-Str. 2 Elmshorn, DE 25335 |
| Contact | Christian Bottcher |
| Correspondent | Christian Bottcher S&C Polymer Silicon- Und Composite Spezialitaten GmbH Robert-Bosch-Str. 2 Elmshorn, DE 25335 |
| Product Code | EJK |
| CFR Regulation Number | 872.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-24 |
| Decision Date | 2020-11-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810092939276 | K202413 | 000 |
| 07350052430403 | K202413 | 000 |
| 07350052430380 | K202413 | 000 |
| 00810118103995 | K202413 | 000 |