The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Voco Profluorid L.
| Device ID | K083036 |
| 510k Number | K083036 |
| Device Name: | VOCO PROFLUORID L |
| Classification | Varnish, Cavity |
| Applicant | VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Contact | M. Plaumann |
| Correspondent | M. 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 | Yes |
| Date Received | 2008-10-14 |
| Decision Date | 2009-01-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22115921 | K083036 | 000 |
| E22115911 | K083036 | 000 |
| E22115901 | K083036 | 000 |
| E2211593 | K083036 | 000 |
| E22115931 | K083036 | 000 |