Device Classification Name |
bracket, ceramic, orthodontic
|
510(k) Number |
K132368 |
FOIA Releasable 510(k) |
K132368
|
Device Name |
VAPOR CERAMIC BRACKET |
Applicant |
ORTHODONTIC DESIGN AND PRODUCTION, INC. |
1370 DECISION STREET |
SUITE D |
VISTA,
CA
92081
|
|
Applicant Contact |
RICHARD MERRELL |
Correspondent |
ORTHODONTIC DESIGN AND PRODUCTION, INC. |
1370 DECISION STREET |
SUITE D |
VISTA,
CA
92081
|
|
Correspondent Contact |
RICHARD MERRELL |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 07/30/2013 |
Decision Date | 12/19/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|