Device Classification Name |
Material, Tooth Shade, Resin
|
510(k) Number |
K970500 |
Device Name |
3M SUSTEL DENTAL SYSTEM |
Applicant |
3M COMPANY |
3M CENTER |
BLDG. 275-3SE-08 |
ST. PAUL,
MN
55144 -1000
|
|
Applicant Contact |
REBECCA L HANNACK |
Correspondent |
3M COMPANY |
3M CENTER |
BLDG. 275-3SE-08 |
ST. PAUL,
MN
55144 -1000
|
|
Correspondent Contact |
REBECCA L HANNACK |
Regulation Number | 872.3690
|
Classification Product Code |
|
Date Received | 02/10/1997 |
Decision Date | 04/30/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|