IMPRESSION TRAY

Material, Impression Tray, Resin

DENTSPLY INTL.

The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Impression Tray.

Pre-market Notification Details

Device IDK872210
510k NumberK872210
Device Name:IMPRESSION TRAY
ClassificationMaterial, Impression Tray, 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 CodeEBH  
CFR Regulation Number872.3670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-09
Decision Date1987-06-22

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