DENTAL COMPOSITE RESTORATIVE

Material, Tooth Shade, Resin

DENTSPLY INTL.

The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Dental Composite Restorative.

Pre-market Notification Details

Device IDK863092
510k NumberK863092
Device Name:DENTAL COMPOSITE RESTORATIVE
ClassificationMaterial, Tooth Shade, Resin
Applicant DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York,  PA  17405
ContactJohn O Semmelman
CorrespondentJohn O Semmelman
DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York,  PA  17405
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-08-13
Decision Date1986-09-19

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