IMPERVA ENSURABOND

Agent, Tooth Bonding, Resin

SHOFU DENTAL CORP.

The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Imperva Ensurabond.

Pre-market Notification Details

Device IDK953613
510k NumberK953613
Device Name:IMPERVA ENSURABOND
ClassificationAgent, Tooth Bonding, Resin
Applicant SHOFU DENTAL CORP. 4025 BOHANNON DR. Menlo Park,  CA  94025 -1096
ContactWilliam Oestreich
CorrespondentWilliam Oestreich
SHOFU DENTAL CORP. 4025 BOHANNON DR. Menlo Park,  CA  94025 -1096
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-02
Decision Date1995-10-04

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