The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Modification To Rebilda Dc.
| Device ID | K060893 |
| 510k Number | K060893 |
| Device Name: | MODIFICATION TO REBILDA DC |
| Classification | Material, Tooth Shade, Resin |
| 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 | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-03 |
| Decision Date | 2006-05-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22114051 | K060893 | 000 |
| E22114061 | K060893 | 000 |
| E22113951 | K060893 | 000 |
| E22113961 | K060893 | 000 |
| E22113971 | K060893 | 000 |
| E22113981 | K060893 | 000 |
| E22114021 | K060893 | 000 |
| E22114031 | K060893 | 000 |
| E22114041 | K060893 | 000 |
| E22113991 | K060893 | 000 |