SmileGuard

Mouthguard, Prescription

EnvisionTEC GmbH

The following data is part of a premarket notification filed by Envisiontec Gmbh with the FDA for Smileguard.

Pre-market Notification Details

Device IDK220894
510k NumberK220894
Device Name:SmileGuard
ClassificationMouthguard, Prescription
Applicant EnvisionTEC GmbH Brusseler Straße 51 Gladbeck,  DE D-45968
ContactRuediger Van Bernum
CorrespondentPatsy J Trisler
Qserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis,  IN  46250
Product CodeMQC  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-28
Decision Date2022-06-10

Trademark Results [SmileGuard]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SMILEGUARD
SMILEGUARD
88827936 not registered Live/Pending
IMPRESS3D, LLC
2020-03-10
SMILEGUARD
SMILEGUARD
77804398 3749815 Live/Registered
CHILDREN ORAL CARE, LLC
2009-08-13
SMILEGUARD
SMILEGUARD
75178328 2196352 Dead/Cancelled
GENERAL AMERICAN LIFE INSURANCE COMPANY
1996-10-07

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