NEW OPAQUE PORCELAIN

Powder, Porcelain

DENTSPLY INTL.

The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for New Opaque Porcelain.

Pre-market Notification Details

Device IDK915543
510k NumberK915543
Device Name:NEW OPAQUE PORCELAIN
ClassificationPowder, Porcelain
Applicant DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York,  PA  17405
ContactJeffery Lehn
CorrespondentJeffery Lehn
DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York,  PA  17405
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-12-10
Decision Date1992-03-19

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