Clear Image Aligner
by Specialty Appliance Works, Inc.
510(k) K071970
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK071970 | Date25 Sep 2007 | 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- Withdrawn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, 20 Sep 2026
The Clear Image Aligner is a Sequential Aligner, a type of dental device designed for the correction of minor to intermediate anterior tooth misalignments. These clear, removable appliances apply gentle, controlled forces to gradually reposition teeth into alignment, providing a non-invasive alternative to traditional braces. The aligners are fabricated in a laboratory setting and are intended for orthodontist-directed treatment, ensuring customised fit and function for each patient.
Clear Image Aligners are supplied as a series of up to five custom-fabricated appliances, intended for single-use per patient. They are classified as Class II medical devices under FDA regulations (872.5470) and were granted FDA 510(k) clearance as substantially equivalent to predicate devices. The aligners are non-sterile, non-reusable, and intended for use in dental offices or orthodontic clinics. No MRI safety information is specified, and the device is not intended for surgical or invasive procedures.
Other devices from Specialty Appliance Works, Inc.
Questions
AI-generated answers, 20 Sep 2026
What types of dental misalignments is the Clear Image Aligner designed to correct, and how does it differ from traditional braces?
The Clear Image Aligner is specifically designed for correcting minor to intermediate anterior tooth misalignments, such as crowding, spacing, or slight rotations of front teeth. Unlike traditional braces, which use fixed metal or ceramic brackets and wires, this device consists of clear, removable aligners that apply gentle, controlled forces to gradually reposition teeth. It is intended for orthodontist-directed treatment, ensuring a custom fit for each patient and offering a non-invasive alternative to braces.
How many aligners are provided in a typical series for a patient, and are they reusable?
A typical series for the Clear Image Aligner includes up to five custom-fabricated appliances, each intended for single-use per patient. They are explicitly labeled as non-reusable, meaning each aligner is designed for one patient’s treatment only. This ensures hygiene and customization for optimal results.
Where and how should the Clear Image Aligner be stored, and is it sterile?
The Clear Image Aligner is non-sterile and intended for use in dental offices or orthodontic clinics. Since it is single-use and non-reusable, storage should follow standard protocols for non-sterile medical devices. It is not intended for surgical or invasive procedures, so no special sterile storage is required. Always store aligners in a clean, dry environment away from direct sunlight or extreme temperatures.
What regulatory pathway was followed for FDA clearance of the Clear Image Aligner, and what does this mean for clinicians?
The Clear Image Aligner received FDA 510(k) clearance through a traditional review process, demonstrating it is substantially equivalent to predicate devices. This means the device meets FDA standards for safety and effectiveness as a Class II medical device (product code NXC) under regulation 872.5470. Clinicians can rely on this clearance as evidence that the aligner has undergone rigorous evaluation for its intended use in orthodontic treatment.