UniSmile Clear Aligner System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K191837 FDA 510(k)
- FDA Product Code
- NXC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.5470 FDA 510(k)
- Regulation Number
- 872.5470 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The UniSmile Clear Aligner System is a removable dental appliance designed for orthodontic treatment to gradually reposition teeth. Classified as a sequential aligner, it applies controlled forces to correct misalignments, crowding, spacing, or bite issues through a series of custom-fitted trays.
Used in dental offices and orthodontic clinics, the system consists of reusable aligners fabricated from proprietary materials for durability and clarity. Each aligner is tailored to specific treatment stages, requiring no sterilization between patients. The device operates under FDA 510(k) clearance (K191837) and adheres to dental medical specialty regulations, with no third-party involvement in distribution.
Frequently asked questions
How is the UniSmile Clear Aligner System different from other removable aligners in terms of its design and intended use?
The UniSmile Clear Aligner System is specifically designed as a sequential aligner, meaning it uses a series of custom-fitted trays to gradually reposition teeth over time. Unlike some other removable aligners, these trays are reusable and made from proprietary materials that prioritize durability and clarity. The system is intended for correcting common orthodontic issues like misalignments, crowding, spacing, and bite problems, and it is tailored for use in dental offices and orthodontic clinics.
Are the UniSmile Clear Aligner trays single-use or reusable, and what does that mean for patient care?
The UniSmile Clear Aligner trays are reusable and designed for multiple treatment stages. Since they are not single-use, they do not require sterilization between patients, which simplifies workflow and reduces handling risks in clinical settings. Each tray is tailored to a specific phase of treatment, ensuring precise force application as teeth gradually move into alignment.
What regulatory pathway was followed for FDA clearance of the UniSmile Clear Aligner System, and what does that mean for clinicians?
The UniSmile Clear Aligner System received FDA 510(k) clearance (K191837) under a traditional review process, with a determination of substantial equivalence to predicate devices. This means the device was evaluated against existing aligners already on the market, confirming it meets safety and effectiveness standards for sequential dental aligners. Clinicians can rely on this clearance as evidence of regulatory compliance for use in orthodontic treatment.
How does the manufacturer ensure the clarity and durability of the UniSmile Clear Aligner trays during treatment?
The UniSmile Clear Aligner System uses proprietary materials specifically formulated for clarity and durability, allowing for consistent visibility and patient comfort throughout treatment. The reusable design ensures the trays maintain structural integrity across multiple stages, reducing wear and tear while delivering controlled orthodontic forces.
What types of orthodontic issues can the UniSmile Clear Aligner System address, and how does the sequential approach work?
The UniSmile Clear Aligner System is designed to address common orthodontic concerns such as misalignments, crowding, spacing, and bite issues by applying controlled forces through a series of custom-fitted trays. The sequential approach means each tray is tailored to a specific treatment phase, gradually guiding teeth into proper alignment over time. This method allows for precise, incremental adjustments without the need for invasive procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Unismile | Boost your dental business with clear aligners, Vitang Intro | Unismile, Vitang Technology- Digital Dental Studio, Vitang Technology LLC - 653455 - 06/12/2023 | FDA
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191837 | Class II | Active |
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Manufacturer
- Manufacturer
- Vitang Technology, LLC
Sources (1)
- FDA 510(k) K191837 24 fields · synced Sep 19, 2026