ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIAL

Crown And Bridge, Temporary, Resin

WALLACE A. ERICKSON & CO.

The following data is part of a premarket notification filed by Wallace A. Erickson & Co. with the FDA for Alpha-dent Temporary Crown And Bridge Material.

Pre-market Notification Details

Device IDK960122
510k NumberK960122
Device Name:ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIAL
ClassificationCrown And Bridge, Temporary, Resin
Applicant WALLACE A. ERICKSON & CO. 1920 NORTH CLYBOURN AVE. Chicago,  IL  60614
ContactAbner T De La Cruz
CorrespondentAbner T De La Cruz
WALLACE A. ERICKSON & CO. 1920 NORTH CLYBOURN AVE. Chicago,  IL  60614
Product CodeEBG  
CFR Regulation Number872.3770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-01-16
Decision Date1996-02-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D77819312570 K960122 000
D73511300060020 K960122 000
D73511300070020 K960122 000
D73511300080020 K960122 000
D73511300090020 K960122 000
D77819312410 K960122 000
D77819312430 K960122 000
D77819312450 K960122 000
D77819312500 K960122 000
D73511300050020 K960122 000

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