The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Grandtec.
| Device ID | K102347 |
| 510k Number | K102347 |
| Device Name: | GRANDTEC |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Contact | T Gerkensmeier |
| Correspondent | T Gerkensmeier VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-19 |
| Decision Date | 2010-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22111681 | K102347 | 000 |
| E22111690 | K102347 | 000 |