E-Guard
Mouthguard, Prescription
EnvisionTEC GmbH
The following data is part of a premarket notification filed by Envisiontec Gmbh with the FDA for E-guard.
Pre-market Notification Details
| Device ID | K201173 |
| 510k Number | K201173 |
| Device Name: | E-Guard |
| Classification | Mouthguard, Prescription |
| Applicant | EnvisionTEC GmbH Brusseler Strabe 51 Gladbeck, DE D-45968 |
| Contact | Ruediger Van Bernum |
| Correspondent | Patsy J. Trisler Qserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, IN 46250 |
| Product Code | MQC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-01 |
| Decision Date | 2020-11-27 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260683220102 | K201173 | 000 |
| 04260683220041 | K201173 | 000 |
Trademark Results [E-Guard]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 E-GUARD 86916733 5287099 Live/Registered |
Envisiontec GmbH 2016-02-23 |
 E-GUARD 77216508 3388358 Dead/Cancelled |
VenTek LLC 2007-06-27 |
 E-GUARD 76249982 2648629 Dead/Cancelled |
BRADY WORLDWIDE, INC. 2001-05-02 |
 E-GUARD 76228860 not registered Dead/Abandoned |
MasterCard International Incorporated 2001-03-09 |
 E-GUARD 76228859 not registered Dead/Abandoned |
MasterCard International Incorporated 2001-03-09 |
 E-GUARD 76228858 not registered Dead/Abandoned |
MasterCard International Incorporated 2001-03-09 |
 E-GUARD 76228857 not registered Dead/Abandoned |
MasterCard International Incorporated 2001-03-09 |
 E-GUARD 75553100 not registered Dead/Abandoned |
Enclosure Technologies, Inc. 1998-09-15 |
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