Cleared Traditional

K160720 - Carriere Motion Clear Class II

K160720 is an FDA 510(k) clearance for Carriere Motion Clear Class II, manufactured by Ortho Organizers, Inc.. The device is a Class 2 Dental device with product code DYW cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K160720 · Ortho Organizers, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
257d
Days
Class 2
Risk

K160720 is an FDA 510(k) clearance for the Carriere Motion Clear Class II. Classified as Bracket, Plastic, Orthodontic (product code DYW), Class II - Special Controls.

Submitted by Ortho Organizers, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 28, 2016 after a review of 257 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ortho Organizers, Inc. devices

FDA 510(k) Submission Details - K160720

510(k) Number K160720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 127d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYW Device Classification - Class 2, Special Controls

Product Code DYW Bracket, Plastic, Orthodontic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DYW Bracket, Plastic, Orthodontic

All 23
Devices cleared under the same product code (DYW) and FDA review panel - the closest regulatory comparables to K160720.
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INSIGNIA WITH ITERO
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INSIGNIA
K121524 · Ormco Corp. · Aug 2012