MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE

Bracket, Metal, Orthodontic

AMERICAN ORTHODONTICS

The following data is part of a premarket notification filed by American Orthodontics with the FDA for Modified X-ring And Speed Stix Plastice Ligature.

Pre-market Notification Details

Device IDK900488
510k NumberK900488
Device Name:MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE
ClassificationBracket, Metal, Orthodontic
Applicant AMERICAN ORTHODONTICS 1714 CAMBRIDGE AVE. Sheboygan,  WI  53081
ContactPaul Riddle
CorrespondentPaul Riddle
AMERICAN ORTHODONTICS 1714 CAMBRIDGE AVE. Sheboygan,  WI  53081
Product CodeEJF  
CFR Regulation Number872.5410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-01-30
Decision Date1990-06-01

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