The following data is part of a premarket notification filed by Bego Bremer Goldschlagerei Wilh. Herbst Gmbh & Co. Kg with the FDA for Varseosmile Temp.
| Device ID | K193553 |
| 510k Number | K193553 |
| Device Name: | VarseoSmile Temp |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | BEGO Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG Wilhelm-Herbst-Str. 1 Bremen, DE 28359 |
| Contact | Tanja Gotz |
| Correspondent | Tanja Gotz BEGO Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG Wilhelm-Herbst-Str. 1 Bremen, DE 28359 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-20 |
| Decision Date | 2020-05-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBGOFLTCC201US2 | K193553 | 000 |
| EBGO41026US1 | K193553 | 000 |
| EBGO41106US1 | K193553 | 000 |
| D040711871 | K193553 | 000 |
| D040711881 | K193553 | 000 |
| D040711891 | K193553 | 000 |
| EBGO41022US1 | K193553 | 000 |
| EBGO41023US1 | K193553 | 000 |
| EBGO41024US1 | K193553 | 000 |
| EBGO41102US1 | K193553 | 000 |
| EBGO41103US1 | K193553 | 000 |
| EBGO41104US1 | K193553 | 000 |
| EBGOFLTCA201US2 | K193553 | 000 |
| EBGOFLTCA301US2 | K193553 | 000 |
| EBGOFLTCB101US2 | K193553 | 000 |
| FLTCBL01US1 | K193553 | 000 |