Device Classification Name |
bracket, ceramic, orthodontic
|
510(k) Number |
K102803 |
FOIA Releasable 510(k) |
K102803
|
Device Name |
CLARITY ADVANCED CERAMIC BRACKETS |
Applicant |
3M UNITEK CORPORATION |
2724 SOUTH PECK RD. |
MONROVIA,
CA
91016
|
|
Applicant Contact |
MARLYN L SCHEFF |
Correspondent |
3M UNITEK CORPORATION |
2724 SOUTH PECK RD. |
MONROVIA,
CA
91016
|
|
Correspondent Contact |
MARLYN L SCHEFF |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 09/28/2010 |
Decision Date | 02/17/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|