Device Classification Name |
bracket, ceramic, orthodontic
|
510(k) Number |
K042905 |
Device Name |
NEO-CLIP ORTHODONTIC BRACKET ACCESSORY |
Applicant |
DENTSPLY INTL. |
221 WEST PHILADELPHIA STREET |
SUITE 60 |
YORK,
PA
17404
|
|
Applicant Contact |
HELEN LEWIS |
Correspondent |
DENTSPLY INTL. |
221 WEST PHILADELPHIA STREET |
SUITE 60 |
YORK,
PA
17404
|
|
Correspondent Contact |
HELEN LEWIS |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 10/21/2004 |
Decision Date | 11/04/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|