PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR

Agent, Tooth Bonding, Resin

DENTSPLY INTL.

The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Prime & Bond 2.1 M.p. Dentin/enamel Bonding Agent W/activator.

Pre-market Notification Details

Device IDK964525
510k NumberK964525
Device Name:PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR
ClassificationAgent, Tooth Bonding, Resin
Applicant DENTSPLY INTL. 500 WEST COLLEGE AVE. York,  PA  17405
ContactP. Jeffery Lehn
CorrespondentP. Jeffery Lehn
DENTSPLY INTL. 500 WEST COLLEGE AVE. York,  PA  17405
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-12
Decision Date1997-01-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D0026344020 K964525 000
D6870099405FG2 K964525 000

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