YAMAHACHI PMMA DISKS

Crown And Bridge, Temporary, Resin

YAMAHACHI DENTAL PRODUCTS USA, INC.

The following data is part of a premarket notification filed by Yamahachi Dental Products Usa, Inc. with the FDA for Yamahachi Pmma Disks.

Pre-market Notification Details

Device IDK151764
510k NumberK151764
Device Name:YAMAHACHI PMMA DISKS
ClassificationCrown And Bridge, Temporary, Resin
Applicant YAMAHACHI DENTAL PRODUCTS USA, INC. 160 PARK AVENUE Nutley,  NJ  07110
ContactLawrence G. Greenwald
CorrespondentJohn F. Gillespy
DENTERPRISE INTERNATIONAL, INC. 100 EAST GRANADA BLVD SUITE 219 Ormond Beach,  FL  32176
Product CodeEBG  
CFR Regulation Number872.3770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-30
Decision Date2015-11-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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