Carriere Motion Clear Class II
510(k) K160720
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK160720 | Date28 Nov 2016 | StatusActive |
Official records
- FDA 510(k) database K160720
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DYW
- Device class
- Class II
- Regulation
- 21 CFR Part 872.5470
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Carriere Motion Clear Class II is a direct-bond, two-piece orthodontic appliance designed to correct posterior occlusion to Class I alignment. It consists of a polyethersulfone anterior pad/arm and a 17-4 stainless steel posterior pad connected via a ball-and-socket joint, facilitating controlled force application during orthodontic treatment.
This device is intended for clinical dental use, bonded to maxillary canine, premolar, and molar teeth. Supplied as a single-use, non-sterile product, it adheres to FDA 510(k) clearance (K160720) under Traditional review in the Dental advisory committee category. Compliance with regulation 872.5470 ensures adherence to orthodontic appliance standards.
From the manufacturer
Carriere System Philosophy The Carriere System incorporates fast, natural, and gentle forces to correct Class II and Class III malocclusions at the beginning of treatment with Carriere® Motion™ Appliances, and then transitions to the Carriere SLX 3D™ Self-Ligating Bracket System to provide efficiencies over traditional mechanics.