The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Futurabond Nr Single Dose.
| Device ID | K053392 |
| 510k Number | K053392 |
| Device Name: | FUTURABOND NR SINGLE DOSE |
| Classification | Agent, Tooth Bonding, 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 | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-12-05 |
| Decision Date | 2005-12-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22126011 | K053392 | 000 |
| E22111531 | K053392 | 000 |
| E22111521 | K053392 | 000 |
| E22111481 | K053392 | 000 |