TEMPORARY CROWN AND BRIDGE MATERIAL

Crown And Bridge, Temporary, Resin

J. MORITA USA, INC.

The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Temporary Crown And Bridge Material.

Pre-market Notification Details

Device IDK020157
510k NumberK020157
Device Name:TEMPORARY CROWN AND BRIDGE MATERIAL
ClassificationCrown And Bridge, Temporary, Resin
Applicant J. MORITA USA, INC. 601 13TH STREET, N.W. SUITE 500 NORTH Washington,  DC  20005
ContactKeith A Barritt
CorrespondentKeith A Barritt
J. MORITA USA, INC. 601 13TH STREET, N.W. SUITE 500 NORTH Washington,  DC  20005
Product CodeEBG  
CFR Regulation Number872.3770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-01-17
Decision Date2002-03-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
18522530060235 K020157 000
18522530060228 K020157 000
10852253006233 K020157 000
10852253006226 K020157 000

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