DEN-MAT DENTIN BONDING AGENT

Agent, Tooth Bonding, Resin

DEN-MAT CORP.

The following data is part of a premarket notification filed by Den-mat Corp. with the FDA for Den-mat Dentin Bonding Agent.

Pre-market Notification Details

Device IDK801216
510k NumberK801216
Device Name:DEN-MAT DENTIN BONDING AGENT
ClassificationAgent, Tooth Bonding, Resin
Applicant DEN-MAT CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-05-21
Decision Date1980-05-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D813032245101B0 K801216 000
D8130304129010 K801216 000
D8130304129020 K801216 000
D8130304510100 K801216 000
D8130311451000 K801216 000
D813031145110B0 K801216 000
D813031145201B0 K801216 000
D8130311453000 K801216 000
D8130311457000 K801216 000
D8130311481000 K801216 000
D8130304119000 K801216 000

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