ORTHODONTIC PLASTIC BRACKET

Bracket, Plastic, Orthodontic

AMERICAN ORTHODONTICS

The following data is part of a premarket notification filed by American Orthodontics with the FDA for Orthodontic Plastic Bracket.

Pre-market Notification Details

• Device ID: K891372
• 510k Number: K891372
• Device Name: ORTHODONTIC PLASTIC BRACKET
• Classification: Bracket, Plastic, Orthodontic
• Applicant: AMERICAN ORTHODONTICS 1714 CAMBRIDGE AVE. Sheboygan, WI 53081
• Contact: Paul Riddle
• Correspondent: Paul Riddle; AMERICAN ORTHODONTICS 1714 CAMBRIDGE AVE. Sheboygan, WI 53081
• Product Code: DYW
• CFR Regulation Number: 872.5470 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1989-03-09
• Decision Date: 1989-03-31

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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00190746003219	K891372	000
00190746003202	K891372	000
00190746003196	K891372	000
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00190746003639	K891372	000
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00190746003561	K891372	000
00190746003394	K891372	000