Dentca Base Premium, Dentca Base Hi-Impact

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 Base Premium, Dentca Base Hi-impact.

Pre-market Notification Details

Device IDK220042
510k NumberK220042
Device Name:Dentca Base Premium, Dentca Base Hi-Impact
ClassificationResin, Denture, Relining, Repairing, Rebasing
Applicant Dentca, Inc. 357 Van Ness Way, Ste 250 Torrance,  CA  90501
ContactJason Lee
CorrespondentJason Lee
Dentca, Inc. 357 Van Ness Way, Ste 250 Torrance,  CA  90501
Product CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-05
Decision Date2022-11-17

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