Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K992538 |
Device Name |
AMORPHOUS DIAMOND COATED SCREW |
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 | 872.3640
|
Classification Product Code |
|
Date Received | 07/30/1999 |
Decision Date | 11/23/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|