The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Solobond Plus.
| Device ID | K003153 |
| 510k Number | K003153 |
| Device Name: | SOLOBOND PLUS |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | VOCO GMBH 7527 WESTMORELAND AVE. St. Louis, MO 63105 |
| Contact | Evan Dick |
| Correspondent | Evan Dick VOCO GMBH 7527 WESTMORELAND AVE. St. Louis, MO 63105 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-10 |
| Decision Date | 2000-11-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22110491 | K003153 | 000 |
| E22110481 | K003153 | 000 |
| E22110441 | K003153 | 000 |