The following data is part of a premarket notification filed by Saremco Dental Ag with the FDA for Saremco Print Crowntec.
| Device ID | K213343 |
| 510k Number | K213343 |
| Device Name: | Saremco Print CROWNTEC |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Saremco Dental AG Gewerbestrasse 4 Rebstein, CH Ch-9445 |
| Contact | Franca Schmid |
| Correspondent | Nevine Erian BQC Consulting, LLC 24341 Barbados Dr. Dana Point, CA 92629 |
| Product Code | EBF |
| Subsequent Product Code | EBG |
| Subsequent Product Code | PZY |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-07 |
| Decision Date | 2022-01-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D93180661 | K213343 | 000 |
| D93180651 | K213343 | 000 |
| D93180631 | K213343 | 000 |
| D93180521 | K213343 | 000 |
| D93180511 | K213343 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SAREMCO PRINT CROWNTEC 97785335 not registered Live/Pending |
Saremco Dental AG 2023-02-08 |