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 |