REVOLUTION BOND

Agent, Tooth Bonding, Resin

E&D DENTAL PRODUCTS, INC.

The following data is part of a premarket notification filed by E&d Dental Products, Inc. with the FDA for Revolution Bond.

Pre-market Notification Details

Device IDK953592
510k NumberK953592
Device Name:REVOLUTION BOND
ClassificationAgent, Tooth Bonding, Resin
Applicant E&D DENTAL PRODUCTS, INC. 71 VERONICA AVE. SUITE 3 Somerset,  NJ  08873
ContactEd Spehar
CorrespondentEd Spehar
E&D DENTAL PRODUCTS, INC. 71 VERONICA AVE. SUITE 3 Somerset,  NJ  08873
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-01
Decision Date1995-09-07

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