BOND-1 C & B

Agent, Tooth Bonding, Resin

JENERIC/PENTRON, INC.

The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Bond-1 C & B.

Pre-market Notification Details

Device IDK013543
510k NumberK013543
Device Name:BOND-1 C & B
ClassificationAgent, Tooth Bonding, Resin
Applicant JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford,  CT  06492 -0724
ContactAnnmarie Tenero
CorrespondentAnnmarie Tenero
JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford,  CT  06492 -0724
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-10-17
Decision Date2002-02-22
Summary:summary

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