D/SENSE-T

Agent, Tooth Bonding, Resin

CENTRIX, INC.

The following data is part of a premarket notification filed by Centrix, Inc. with the FDA for D/sense-t.

Pre-market Notification Details

Device IDK973285
510k NumberK973285
Device Name:D/SENSE-T
ClassificationAgent, Tooth Bonding, Resin
Applicant CENTRIX, INC. 770 RIVER RD. Shelton,  CT  06484 -5458
ContactJohn Discko
CorrespondentJohn Discko
CENTRIX, INC. 770 RIVER RD. Shelton,  CT  06484 -5458
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-02
Decision Date1998-02-25

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