NICKLE-TITANIUM ORTHODONTIC WIRE

Detector, Air Bubble

AMERICAN ORTHODONTICS

The following data is part of a premarket notification filed by American Orthodontics with the FDA for Nickle-titanium Orthodontic Wire.

Pre-market Notification Details

Device IDK891327
510k NumberK891327
Device Name:NICKLE-TITANIUM ORTHODONTIC WIRE
ClassificationDetector, Air Bubble
Applicant AMERICAN ORTHODONTICS 1714 CAMBRIDGE AVE. Sheboygan,  WI  53081
ContactPaul Riddle
CorrespondentPaul Riddle
AMERICAN ORTHODONTICS 1714 CAMBRIDGE AVE. Sheboygan,  WI  53081
Product CodeFJF  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-03-10
Decision Date1989-05-10

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