The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Admira Protect/admira Protect Single Dose.
| Device ID | K061823 |
| 510k Number | K061823 |
| Device Name: | ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Contact | Michael Sus |
| Correspondent | Michael Sus VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-28 |
| Decision Date | 2006-07-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22124791 | K061823 | 000 |
| E22124261 | K061823 | 000 |
| E22124251 | K061823 | 000 |
| E22124241 | K061823 | 000 |
| E22124231 | K061823 | 000 |
| E22124221 | K061823 | 000 |
| E22124211 | K061823 | 000 |
| E22124201 | K061823 | 000 |
| E22116521 | K061823 | 000 |
| E22116511 | K061823 | 000 |
| E22124271 | K061823 | 000 |
| E22124281 | K061823 | 000 |
| E22124541 | K061823 | 000 |
| E22124531 | K061823 | 000 |
| E22124521 | K061823 | 000 |
| E22124511 | K061823 | 000 |
| E22124371 | K061823 | 000 |
| E22124321 | K061823 | 000 |
| E22124311 | K061823 | 000 |
| E22124301 | K061823 | 000 |
| E22124291 | K061823 | 000 |
| E22116501 | K061823 | 000 |