Device Classification Name |
Bracket, Ceramic, Orthodontic
|
510(k) Number |
K082974 |
Device Name |
MYSTIQUE MB CERAMIC BRACKETS |
Applicant |
DENTSPLY INTERNTIONAL |
221 W. PHILADELPHIA ST. STE.60 |
SUSQUEHANNA COMMERCE CRT. WEST |
YORK,
PA
17405
|
|
Applicant Contact |
HELEN LEWIS |
Correspondent |
DENTSPLY INTERNTIONAL |
221 W. PHILADELPHIA ST. STE.60 |
SUSQUEHANNA COMMERCE CRT. WEST |
YORK,
PA
17405
|
|
Correspondent Contact |
HELEN LEWIS |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 10/06/2008 |
Decision Date | 11/07/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|