E-Denture Pro

Resin, Denture, Relining, Repairing, Rebasing

EnvisionTEC GmbH

The following data is part of a premarket notification filed by Envisiontec Gmbh with the FDA for E-denture Pro.

Pre-market Notification Details

Device IDK203641
510k NumberK203641
Device Name:E-Denture Pro
ClassificationResin, Denture, Relining, Repairing, Rebasing
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 CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-14
Decision Date2021-03-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04260683220386 K203641 000
04260683220379 K203641 000
04260683220362 K203641 000
04260683220355 K203641 000
04260683220348 K203641 000

Trademark Results [E-Denture Pro]

Mark Image

Registration | Serial
Company
Trademark
Application Date
E-DENTURE PRO
E-DENTURE PRO
90614790 not registered Live/Pending
Envisiontec US LLC
2021-03-31

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