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 |