EASY BOND

Agent, Tooth Bonding, Resin

PARKELL, INC.

The following data is part of a premarket notification filed by Parkell, Inc. with the FDA for Easy Bond.

Pre-market Notification Details

Device IDK972421
510k NumberK972421
Device Name:EASY BOND
ClassificationAgent, Tooth Bonding, Resin
Applicant PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale,  NY  11735
ContactNelson J Gendusa
CorrespondentNelson J Gendusa
PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale,  NY  11735
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-27
Decision Date1997-08-29
Summary:summary

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