Device Classification Name |
alloy, gold-based noble metal |
|||
---|---|---|---|---|
510(k) Number | K024143 | |||
Device Name | AIGIS-FINE | |||
Original Applicant |
|
|||
Original Contact | dae-kyu chang | |||
Regulation Number | 872.3060 | |||
Classification Product Code |
|
|||
Date Received | 12/16/2002 | |||
Decision Date | 03/10/2003 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
Dental |
|||
510k Review Panel |
Dental |
|||
summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |