IMPERVA-A

Material, Tooth Shade, Resin

SHOFU DENTAL CORP.

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

Pre-market Notification Details

Device IDK871899
510k NumberK871899
Device Name:IMPERVA-A
ClassificationMaterial, Tooth Shade, Resin
Applicant SHOFU DENTAL CORP. 4024 BOHANNON DR. Menlo Park,  CA  94025 -1096
ContactAkerkar, Ph.d.
CorrespondentAkerkar, Ph.d.
SHOFU DENTAL CORP. 4024 BOHANNON DR. Menlo Park,  CA  94025 -1096
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-05-15
Decision Date1987-07-21

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