NPG 2 BASE METAL ALLOY

Bracket, Metal, Orthodontic

AALBA DENT, INC.

The following data is part of a premarket notification filed by Aalba Dent, Inc. with the FDA for Npg 2 Base Metal Alloy.

Pre-market Notification Details

Device IDK892419
510k NumberK892419
Device Name:NPG 2 BASE METAL ALLOY
ClassificationBracket, Metal, Orthodontic
Applicant AALBA DENT, INC. 111 N. WABASH Chicago,  IL  60602
ContactBauer, Phd
CorrespondentBauer, Phd
AALBA DENT, INC. 111 N. WABASH Chicago,  IL  60602
Product CodeEJF  
CFR Regulation Number872.5410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-10
Decision Date1989-06-16

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