The following data is part of a premarket notification filed by Driskell Bioengineering with the FDA for Db Precision Implant System, 2000 Series.
| Device ID | K860982 |
| 510k Number | K860982 |
| Device Name: | DB PRECISION IMPLANT SYSTEM, 2000 SERIES |
| Classification | Implant, Endosseous, Root-form |
| Applicant | DRISKELL BIOENGINEERING A DIVISION OF QUINTRON INC. 5229 CHESHIRE ROAD Galena, OH 43021 |
| Contact | Thomas D Driskell |
| Correspondent | Thomas D Driskell DRISKELL BIOENGINEERING A DIVISION OF QUINTRON INC. 5229 CHESHIRE ROAD Galena, OH 43021 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-17 |
| Decision Date | 1986-04-25 |