LIP BUMPER

Bracket, Metal, Orthodontic

AMERICAN ORTHODONTICS

The following data is part of a premarket notification filed by American Orthodontics with the FDA for Lip Bumper.

Pre-market Notification Details

Device IDK890656
510k NumberK890656
Device Name:LIP BUMPER
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 Received1989-02-08
Decision Date1989-04-17

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