Device Classification Name |
Mouthguard, Prescription
|
510(k) Number |
K201173 |
Device Name |
E-Guard |
Applicant |
EnvisionTEC GmbH |
Brusseler Strabe 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 | 05/01/2020 |
Decision Date | 11/27/2020 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|