3M Clear Tray Aligner
510(k) K163689
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK163689 | Date27 Jan 2017 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NXC
- Device class
- Class II
- Regulation
- 21 CFR Part 872.5470
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The 3M Clear Tray Aligner is a sequential aligner system consisting of clear, thermoformed plastic aligners designed for orthodontic tooth movement. Dental professionals assess patients, take molds, and submit prescriptions via standard dental software. 3M designs an incremental tooth movement plan which is reviewed and approved by the physician before custom trays are manufactured.
The aligners are supplied as a system for professional use in dental settings. The device is Class II and has received FDA clearance as substantially equivalent under product code NXC. The system is regulated under 872.5470 and is intended for sequential orthodontic treatment.
Other devices from 3M Unitek Corporation
Questions
AI-generated answers, 25 Sep 2026
What is the 3M Clear Tray Aligner system used for?
The 3M Clear Tray Aligner is a sequential aligner system consisting of clear, thermoformed plastic aligners designed for orthodontic tooth movement. Dental professionals assess patients, take molds, and submit prescriptions via standard dental software.
How is the 3M Clear Tray Aligner system supplied?
The aligners are supplied as a system for professional use in dental settings. The device is Class II and has received FDA clearance as substantially equivalent under product code NXC. The system is regulated under 872.5470 and is intended for sequential orthodontic treatment.
How are the custom aligners manufactured?
3M designs an incremental tooth movement plan which is reviewed and approved by the physician before custom trays are manufactured. This ensures each patient's treatment plan meets their specific orthodontic needs.
What is the regulatory status of the 3M Clear Tray Aligner?
The device has received FDA clearance as substantially equivalent under product code NXC. It is Class II and regulated under 872.5470. The clearance was received on January 27, 2017, with K number K163689.