The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Voco Profluorid Varnish.
| Device ID | K080814 |
| 510k Number | K080814 |
| Device Name: | VOCO PROFLUORID VARNISH |
| Classification | Varnish, Cavity |
| Applicant | VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Contact | M.th Plaumann |
| Correspondent | M.th Plaumann VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-24 |
| Decision Date | 2008-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889950134143 | K080814 | 000 |
| 10302730002253 | K080814 | 000 |
| 20302730002243 | K080814 | 000 |
| 10302730002239 | K080814 | 000 |
| 10302730002222 | K080814 | 000 |
| 20302730002212 | K080814 | 000 |
| 20302730002205 | K080814 | 000 |
| 20302730002199 | K080814 | 000 |
| 10302730002185 | K080814 | 000 |
| 10302730002178 | K080814 | 000 |
| 50732224000317 | K080814 | 000 |
| 10302730003229 | K080814 | 000 |
| 10302730003212 | K080814 | 000 |
| 10302730003205 | K080814 | 000 |
| 10302730003199 | K080814 | 000 |
| 00302730003185 | K080814 | 000 |
| 10302730002260 | K080814 | 000 |
| 20302730002274 | K080814 | 000 |
| 10302739996348 | K080814 | 000 |
| 20302732957336 | K080814 | 000 |
| 10302732957322 | K080814 | 000 |
| 10302732956158 | K080814 | 000 |
| 20302732954847 | K080814 | 000 |
| 20302732184503 | K080814 | 000 |
| 20302732144507 | K080814 | 000 |
| 20302732144200 | K080814 | 000 |
| 20302732134508 | K080814 | 000 |
| 20302732134201 | K080814 | 000 |
| 20302732124509 | K080814 | 000 |
| 20302732124202 | K080814 | 000 |
| 10302732114503 | K080814 | 000 |
| 20302732114203 | K080814 | 000 |
| 10302730002406 | K080814 | 000 |
| 10302730003175 | K080814 | 000 |