DIAMOND D HIGH IMPACT DENTURE ACRYLIC

Resin, Denture, Relining, Repairing, Rebasing

MYCONE DENTAL SUPPLY CO., INC.

The following data is part of a premarket notification filed by Mycone Dental Supply Co., Inc. with the FDA for Diamond D High Impact Denture Acrylic.

Pre-market Notification Details

Device IDK032773
510k NumberK032773
Device Name:DIAMOND D HIGH IMPACT DENTURE ACRYLIC
ClassificationResin, Denture, Relining, Repairing, Rebasing
Applicant MYCONE DENTAL SUPPLY CO., INC. 616 HOLLYWOOD AVE. Cherry Hill,  NJ  08002
ContactLarry Steffier
CorrespondentLarry Steffier
MYCONE DENTAL SUPPLY CO., INC. 616 HOLLYWOOD AVE. Cherry Hill,  NJ  08002
Product CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-08
Decision Date2003-09-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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H66810130591 K032773 000

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