The following data is part of a premarket notification filed by Bego Bremer Goldschlägerei Wilh. Herbst Gmbh & Co. Kg with the FDA for Varseosmile Crown Plus.
| Device ID | K201668 |
| 510k Number | K201668 |
| Device Name: | VarseoSmile Crown Plus |
| Classification | Material, Tooth Shade, Resin |
| Applicant | BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG Wilhelm-Herbst-Straße 1 Bremen, DE 28359 |
| Contact | Tanja Goetz |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-06-19 |
| Decision Date | 2020-06-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBGOSRI02050402 | K201668 | 000 |
| EBGO41107US1 | K201668 | 000 |
| EBGO41108US1 | K201668 | 000 |
| EBGO41109US1 | K201668 | 000 |
| EBGO41110US1 | K201668 | 000 |
| EBGO41111US1 | K201668 | 000 |
| EBGO41112US1 | K201668 | 000 |
| EBGO41113US1 | K201668 | 000 |
| EBGO41117US1 | K201668 | 000 |
| EBGO41118US1 | K201668 | 000 |
| EBGO41119US1 | K201668 | 000 |
| EBGO41120US1 | K201668 | 000 |
| EBGO41121US1 | K201668 | 000 |
| EBGO41124US1 | K201668 | 000 |
| EBGO41114US1 | K201668 | 000 |
| EBGOSRI02050461 | K201668 | 000 |
| EBGOSRI02050412 | K201668 | 000 |
| EBGOSRI02050422 | K201668 | 000 |
| EBGOSRI02050432 | K201668 | 000 |
| EBGOSRI02050442 | K201668 | 000 |
| EBGOSRI02050452 | K201668 | 000 |
| EBGOSRI02050462 | K201668 | 000 |
| EBGOSRI02050401 | K201668 | 000 |
| EBGOSRI02050411 | K201668 | 000 |
| EBGOSRI02050421 | K201668 | 000 |
| EBGOSRI02050431 | K201668 | 000 |
| EBGOSRI02050441 | K201668 | 000 |
| EBGOSRI02050451 | K201668 | 000 |
| EBGO41122US1 | K201668 | 000 |
| EBGO41123US1 | K201668 | 000 |
| EBGO41108 | K201668 | 000 |
| EBGO41109 | K201668 | 000 |
| EBGO41110 | K201668 | 000 |
| EBGO41111 | K201668 | 000 |
| EBGO41112 | K201668 | 000 |
| EBGO41113 | K201668 | 000 |
| EBGO41117 | K201668 | 000 |
| EBGO41118 | K201668 | 000 |
| EBGO41119 | K201668 | 000 |
| EBGO41120 | K201668 | 000 |
| EBGO41121 | K201668 | 000 |
| EBGO41122 | K201668 | 000 |
| EBGO41107 | K201668 | 000 |
| EBGOFLPCC201 | K201668 | 000 |
| EBGOFLPCB101 | K201668 | 000 |
| EBGOFLPCA201US1 | K201668 | 000 |
| EBGOFLPCA301US1 | K201668 | 000 |
| EBGOFLPCB101US1 | K201668 | 000 |
| EBGOFLPCC201US1 | K201668 | 000 |
| D040711911 | K201668 | 000 |
| D040711931 | K201668 | 000 |
| D040711941 | K201668 | 000 |
| D040711951 | K201668 | 000 |
| D040711961 | K201668 | 000 |
| D040711971 | K201668 | 000 |
| EBGOFLPCA201 | K201668 | 000 |
| EBGOFLPCA301 | K201668 | 000 |
| EBGO41123 | K201668 | 000 |