PacBond One

Agent, Tooth Bonding, Resin

Pac-Dent, Inc.

The following data is part of a premarket notification filed by Pac-dent, Inc. with the FDA for Pacbond One.

Pre-market Notification Details

Device IDK210186
510k NumberK210186
Device Name:PacBond One
ClassificationAgent, Tooth Bonding, Resin
Applicant Pac-Dent, Inc. 670 Endeavor Circle Brea,  CA  92821
ContactTom Peng
CorrespondentTom Peng
Pac-Dent, Inc. 670 Endeavor Circle Brea,  CA  92821
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-25
Decision Date2021-07-16

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