EtchPro Etching Gel

Agent, Tooth Bonding, Resin

Belport Company, Inc., Gingi-Pak

The following data is part of a premarket notification filed by Belport Company, Inc., Gingi-pak with the FDA for Etchpro Etching Gel.

Pre-market Notification Details

Device IDK200462
510k NumberK200462
Device Name:EtchPro Etching Gel
ClassificationAgent, Tooth Bonding, Resin
Applicant Belport Company, Inc., Gingi-Pak 4825 Calle Alto, Camarillo,  CA  93012
ContactDaniel Wang
CorrespondentDaisy Ni
Belport Company, Inc., Gingi-Pak 4825 Calle Alto, Camarillo,  CA  93012
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-25
Decision Date2020-09-02

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