ClearCorrect Aligner, Sequential
510(k) K082556
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK082556 | Date6 Feb 2009 | 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- Withdrawn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
- Full name
- Clearcorrect
- 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, 19 Sep 2026
The ClearCorrect Aligner, Sequential is a removable orthodontic appliance designed for the gradual correction of dental alignment. Classified as a sequential aligner, it applies controlled force to incrementally reposition teeth over time, addressing mild to moderate malocclusions without fixed brackets or wires.
These aligners are supplied as a series of custom-fabricated, clear thermoplastic trays, each worn sequentially for approximately two weeks before advancing to the next in the prescribed sequence. They are intended for single-use per tray and require no sterilization, as they are not reusable. The device is regulated under FDA 510(k) clearance (K082556) as a Class II medical device under regulation 872.5470, with no MRI safety restrictions specified. Sizes and fit are determined by patient-specific impressions and digital scans, ensuring precise alignment correction.
Other devices from Clearcorrect, Inc.
Questions
AI-generated answers, 19 Sep 2026
How does the ClearCorrect Aligner, Sequential differ from traditional fixed orthodontic braces in terms of usage and convenience?
The ClearCorrect Aligner, Sequential is a removable orthodontic appliance designed for gradual dental alignment correction without fixed brackets or wires. Unlike traditional braces, it consists of a series of custom-fabricated, clear thermoplastic trays that patients wear sequentially—each for about two weeks—before advancing to the next in the prescribed sequence. This removable design allows for easier oral hygiene maintenance and greater convenience for eating and speaking, as it can be taken out temporarily.
Are the ClearCorrect Aligner trays reusable, or are they intended for single-use?
The ClearCorrect Aligner trays are explicitly designed for single-use per tray. Each aligner is custom-fabricated for a specific stage in the treatment sequence and is not meant to be reused or sterilized, as they are not intended for repeated use.
How are the sizes and fit of the ClearCorrect Aligner trays determined?
The sizes and fit of the ClearCorrect Aligner trays are determined through patient-specific impressions and digital scans. This ensures precise alignment correction tailored to the individual’s dental structure, allowing for accurate and effective repositioning of teeth over time.
What regulatory pathway was followed for the FDA clearance of the ClearCorrect Aligner, Sequential?
The ClearCorrect Aligner, Sequential was cleared through the FDA’s 510(k) process, specifically under the traditional clearance route (K082556). It is classified as a Class II medical device under regulation 872.5470 and was reviewed by the Dental (DE) Advisory Committee. The clearance was granted on February 6, 2009, after demonstrating substantial equivalence to a predicate device.
Can the ClearCorrect Aligner, Sequential be used in an MRI environment, or are there any safety restrictions?
The ClearCorrect Aligner, Sequential does not have any specified MRI safety restrictions mentioned in its regulatory documentation. However, patients should always confirm with their healthcare provider or MRI facility before use, as individual medical conditions may still pose risks.