Device Classification Name |
mouthguard, prescription
|
510(k) Number |
K220894 |
Device Name |
SmileGuard |
Applicant |
EnvisionTEC GmbH |
Brusseler Straße 51 |
Gladbeck,
DE
D-45968
|
|
Applicant Contact |
Ruediger Van Bernum |
Correspondent |
Qserve Group US, Inc. |
7949 Beaumont Green East Drive |
Indianapolis,
IN
46250
|
|
Correspondent Contact |
Patsy J Trisler |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/28/2022 |
Decision Date | 06/10/2022 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|