Device Classification Name |
material, tooth shade, resin
|
510(k) Number |
K072733 |
Device Name |
3M ESPE ADULT CROWN |
Applicant |
3M COMPANY |
EM CENTER, BLDG. 260-2A-11 |
ST PAUL,
MN
55144 -1000
|
|
Applicant Contact |
SCOTT ERICKSON |
Correspondent |
3M COMPANY |
EM CENTER, BLDG. 260-2A-11 |
ST PAUL,
MN
55144 -1000
|
|
Correspondent Contact |
SCOTT ERICKSON |
Regulation Number | 872.3690
|
Classification Product Code |
|
Date Received | 09/27/2007 |
Decision Date | 02/15/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|