Device Classification Name |
mouthguard, prescription
|
510(k) Number |
K062828 |
Device Name |
MOUTHGUARD AND ALIGNER MATERIALS |
Applicant |
DENTSPLY INTL., INC. |
SUSQUEHANNA COMMERCE CENTER |
221 W PHILADELPHIA ST. STE 60 |
YORK,
PA
17404
|
|
Applicant Contact |
HELEN LEWIS |
Correspondent |
DENTSPLY INTL., INC. |
SUSQUEHANNA COMMERCE CENTER |
221 W PHILADELPHIA ST. STE 60 |
YORK,
PA
17404
|
|
Correspondent Contact |
HELEN LEWIS |
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/20/2006 |
Decision Date | 11/27/2006 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|