Carriere SLX 3D Clear

Bracket, Ceramic, Orthodontic

Ortho Organizers, Inc.

The following data is part of a premarket notification filed by Ortho Organizers, Inc. with the FDA for Carriere Slx 3d Clear.

Pre-market Notification Details

• Device ID: K173440
• 510k Number: K173440
• Device Name: Carriere SLX 3D Clear
• Classification: Bracket, Ceramic, 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: NJM
• CFR Regulation Number: 872.5470 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-11-06
• Decision Date: 2018-03-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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