Cleared Traditional

Carriere Motion Clear Class II

K160720 · Ortho Organizers, Inc. · Dental
Nov 2016
Decision
257d
Days
Class 2
Risk

About This 510(k) Submission

K160720 is an FDA 510(k) clearance for the Carriere Motion Clear Class II, a Bracket, Plastic, Orthodontic (Class II — Special Controls, product code DYW), submitted by Ortho Organizers, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 28, 2016, 257 days after receiving the submission on March 16, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K160720 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 2016
Decision Date November 28, 2016
Days to Decision 257 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DYW — Bracket, Plastic, Orthodontic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.5470

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