DENTCA Crown And Bridge

Crown And Bridge, Temporary, Resin

Dentca, Inc.

The following data is part of a premarket notification filed by Dentca, Inc. with the FDA for Dentca Crown And Bridge.

Pre-market Notification Details

Device IDK192806
510k NumberK192806
Device Name:DENTCA Crown And Bridge
ClassificationCrown And Bridge, Temporary, Resin
Applicant Dentca, Inc. 357 Van Ness Way #250 Torrance,  CA  90501
ContactJason Lee
CorrespondentJoyce St. Germain
The 510k Consulting, LLC 1449 Springleaf Dr Ormond Beach,  FL  32174
Product CodeEBG  
CFR Regulation Number872.3770 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
510k Review PanelDental
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-01
Decision Date2020-02-05

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