The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Solobond M.
| Device ID | K980539 |
| 510k Number | K980539 |
| Device Name: | SOLOBOND M |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | VOCO GMBH 7527 WESTMORELAND AVE. St. Louis, MO 63105 |
| Contact | Evan Dick, Ph.d. |
| Correspondent | Evan Dick, Ph.d. 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 | 1998-02-12 |
| Decision Date | 1998-03-23 |