EXCELSIOR PORCELAIN SYSTEM

Powder, Porcelain

NEY DENTAL, INC.

The following data is part of a premarket notification filed by Ney Dental, Inc. with the FDA for Excelsior Porcelain System.

Pre-market Notification Details

Device IDK984427
510k NumberK984427
Device Name:EXCELSIOR PORCELAIN SYSTEM
ClassificationPowder, Porcelain
Applicant NEY DENTAL, INC. 1065 S.W. 30TH AVE. Deerfield Beach,  FL  33442 -8193
ContactAndrew J Pietrobono
CorrespondentAndrew J Pietrobono
NEY DENTAL, INC. 1065 S.W. 30TH AVE. Deerfield Beach,  FL  33442 -8193
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-12-11
Decision Date1999-03-15

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