Carriere Motion Clear Class II

Bracket, Plastic, Orthodontic

ORTHO ORGANIZERS, INC.

The following data is part of a premarket notification filed by Ortho Organizers, Inc. with the FDA for Carriere Motion Clear Class Ii.

Pre-market Notification Details

• Device ID: K160720
• 510k Number: K160720
• Device Name: Carriere Motion Clear Class II
• Classification: Bracket, Plastic, Orthodontic
• Applicant: ORTHO ORGANIZERS, INC. 1822 ASTON AVENUE Carlsbad, CA 92008
• Contact: Colleen Boswell
• Correspondent: Colleen Boswell; ORTHO ORGANIZERS, INC. 1822 ASTON AVENUE Carlsbad, CA 92008
• Product Code: DYW
• CFR Regulation Number: 872.5470 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-03-16
• Decision Date: 2016-11-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10190707102927	K160720	000
00190707103057	K160720	000
10190707103061	K160720	000
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10190707103030	K160720	000
10190707102934	K160720	000
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10190707102972	K160720	000
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