Identifiers
- 510(k) Number
- K101951 FDA 510(k)
- FDA Product Code
- DYH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3750 FDA 510(k)
- Regulation Number
- 872.3750 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Light Cure Retainer is a dental adhesive, resin-based device designed for bonding lingual retainers, creating occlusal buildups, and retaining thermoplastic aligners. It falls under the category of adhesive, bracket, and tooth conditioner, utilizing a light-activated curing mechanism to achieve durable bonding in orthodontic applications. The material is formulated for precision and stability in dental restorative procedures.
Supplied as a flowable, light-curable composite in push syringes (available in 5g and 1.5g variants), the device is intended for use exclusively in dental, orthodontic, or pediatric dental offices. It is not sterile at the point of sale and requires proper handling and curing under a dental curing light. The device is classified as Class II under FDA regulations and holds a 510(k) clearance for dental applications, adhering to regulatory standards for adhesive resins.
Frequently asked questions
What is the Light Cure Retainer used for in orthodontic treatments?
The Light Cure Retainer is a resin-based adhesive designed specifically for bonding lingual retainers, creating occlusal buildups, and securing thermoplastic aligners. Its light-activated curing mechanism ensures strong, durable bonds in dental restorative procedures, providing stability during orthodontic treatment.
How is the Light Cure Retainer supplied, and what sizes are available?
The device comes in push syringes containing a flowable, light-curable composite. It is available in two sizes: 5g and 1.5g variants, allowing for flexibility depending on the clinical need. The syringes are intended for single-use applications in dental offices.
Is the Light Cure Retainer sterile at the point of sale?
No, the Light Cure Retainer is not sterile at the point of sale. It must be handled according to standard dental protocols and cured under a dental curing light before use to ensure proper adhesion and sterility.
Can the Light Cure Retainer be reused, or is it intended for single-use?
The Light Cure Retainer is formulated for single-use applications. Once cured, the material bonds permanently to dental structures, making reuse unsafe and ineffective. Each syringe should be discarded after one use to maintain clinical standards.
What storage conditions are required for the Light Cure Retainer?
The Light Cure Retainer should be stored in a cool, dry place, protected from direct sunlight and extreme temperatures. Ensure the syringes remain sealed until use to preserve the material’s properties and prevent contamination.
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: Light Cure Retainer Kit - Reliance Orthodontic Products, Light Cure Retainer 5g Push Syringe - Reliance Orthodontic Products, Light Cure Retainer 1.5g Push Syringe with Tips
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K101951 | Class II | Active |
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Manufacturer
- Manufacturer
- Reliance Orthodontic Products, Inc.
Sources (1)
- FDA 510(k) K101951 24 fields · synced Oct 1, 2026