Device Classification Name |
bracket, ceramic, orthodontic
|
510(k) Number |
K073045 |
Device Name |
SAPPHIRE CERAMIC BRACKET |
Applicant |
ORTHO TECHNOLOGY, INC |
17401 COMMERCE PARK BLVD. |
TAMPA,
FL
33647
|
|
Applicant Contact |
PAUL WILLIAMS |
Correspondent |
ORTHO TECHNOLOGY, INC |
17401 COMMERCE PARK BLVD. |
TAMPA,
FL
33647
|
|
Correspondent Contact |
PAUL WILLIAMS |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 10/29/2007 |
Decision Date | 12/18/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|