The following data is part of a premarket notification filed by Driskell Bioengineering with the FDA for Db Precision Implant System.
Device ID | K853788 |
510k Number | K853788 |
Device Name: | DB PRECISION IMPLANT SYSTEM |
Classification | Implant, Endosseous, Root-form |
Applicant | DRISKELL BIOENGINEERING 9040 HAWTHORN POINT Westerville, OH 43081 |
Contact | Thomas D Driskell |
Correspondent | Thomas D Driskell DRISKELL BIOENGINEERING 9040 HAWTHORN POINT Westerville, OH 43081 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-09-10 |
Decision Date | 1985-10-31 |