Device Classification Name |
Agent, Tooth Bonding, Resin
|
510(k) Number |
K041960 |
Device Name |
COMPOSITE/COMPOMER REPAIR KIT |
Applicant |
DMG USA, INC. |
414 SOUTH STATE ST. |
DOVER,
DE
19901
|
|
Applicant Contact |
PAMELA PAPINEAU |
Correspondent |
DMG USA, INC. |
414 SOUTH STATE ST. |
DOVER,
DE
19901
|
|
Correspondent Contact |
PAMELA PAPINEAU |
Regulation Number | 872.3200
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/21/2004 |
Decision Date | 08/30/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|