The following data is part of a premarket notification filed by Nobel Biocare Uas Inc with the FDA for Amorphous Diamond Coated Drill.
| Device ID | K990846 |
| 510k Number | K990846 |
| Device Name: | AMORPHOUS DIAMOND COATED DRILL |
| Classification | Drill, Bone, Powered |
| Applicant | NOBEL BIOCARE UAS INC 22895 EASTPARK DR. Yorba Linda, CA 92887 |
| Contact | Kim Rendon |
| Correspondent | Kim Rendon NOBEL BIOCARE UAS INC 22895 EASTPARK DR. Yorba Linda, CA 92887 |
| Product Code | DZI |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-15 |
| Decision Date | 1999-06-10 |
| Summary: | summary |