Device Classification Name |
Adhesive, Bracket And Tooth Conditioner, Resin
|
510(k) Number |
K760376 |
Device Name |
CEMENT, RESIN DENTAL (SOLO-TACH) |
Applicant |
L.D. CAULK CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
L.D. CAULK CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 872.3750 |
Classification Product Code |
|
Date Received | 08/05/1976 |
Decision Date | 08/23/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|