YAMAHACHI DENTURE BASE RESINS

Resin, Denture, Relining, Repairing, Rebasing

YAMAHACHI DENTAL MANUFACTURING CO.

The following data is part of a premarket notification filed by Yamahachi Dental Manufacturing Co. with the FDA for Yamahachi Denture Base Resins.

Pre-market Notification Details

Device IDK131036
510k NumberK131036
Device Name:YAMAHACHI DENTURE BASE RESINS
ClassificationResin, Denture, Relining, Repairing, Rebasing
Applicant YAMAHACHI DENTAL MANUFACTURING CO. 110 EASTGRANADA BLVD. SUITE 209 Ormond Beach,  FL  32176
ContactClaude Berthoin
CorrespondentClaude Berthoin
YAMAHACHI DENTAL MANUFACTURING CO. 110 EASTGRANADA BLVD. SUITE 209 Ormond Beach,  FL  32176
Product CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-04-15
Decision Date2013-07-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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