Device Classification Name |
drill, bone, powered
|
510(k) Number |
K990846 |
Device Name |
AMORPHOUS DIAMOND COATED DRILL |
Applicant |
NOBEL BIOCARE UAS INC |
22895 EASTPARK DR. |
YORBA LINDA,
CA
92887
|
|
Applicant Contact |
KIM RENDON |
Correspondent |
NOBEL BIOCARE UAS INC |
22895 EASTPARK DR. |
YORBA LINDA,
CA
92887
|
|
Correspondent Contact |
KIM RENDON |
Regulation Number | 872.4120
|
Classification Product Code |
|
Date Received | 03/15/1999 |
Decision Date | 06/10/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|