Dentca Denture Base II

Resin, Denture, Relining, Repairing, Rebasing

DENTCA, Inc.

The following data is part of a premarket notification filed by Dentca, Inc. with the FDA for Dentca Denture Base Ii.

Pre-market Notification Details

Device IDK162044
510k NumberK162044
Device Name:Dentca Denture Base II
ClassificationResin, Denture, Relining, Repairing, Rebasing
Applicant DENTCA, Inc. 357 Van Ness Way #250 Torrance,  CA  90501
ContactJason Lee
CorrespondentClaude Berthoin
Denterprise International, Inc. 100 East Granada Blvd., Suite 219 Ormond Beach,  FL  32176
Product CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-07-25
Decision Date2017-03-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00856551007278 K162044 000
J01466075560 K162044 000
00810002220128 K162044 000
00856551007001 K162044 000
00856551007209 K162044 000
00856551007216 K162044 000
00856551007230 K162044 000
00856551007247 K162044 000
00856551007254 K162044 000
00856551007261 K162044 000
J01466075558 K162044 000

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