Light Bond Sealant With Fluoride
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K894565 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 Bond Sealant With Fluoride is a light-cure resin adhesive, bracket, and tooth conditioner designed for orthodontic applications. It provides a bonding interface between brackets, tubes, or attachments and tooth surfaces, ensuring secure fixation during orthodontic treatment. The fluoride-infused formulation also contributes to remineralization and caries prevention on treated enamel surfaces.
Supplied in 3 cc or 7 cc bottles, this single-use adhesive is intended for clinical use in dental offices. It requires activation via a curing light and is classified as a Class II medical device under FDA regulations (K894565, 510K clearance). Sterility is not specified, but standard aseptic handling procedures apply. Compatibility with orthodontic brackets, tubes, and ceramic/composite attachments is supported, with no noted MRI safety restrictions. Storage follows standard dental adhesive protocols.
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 Bond | Reliance Orthodontics Products, Light Bond Sealant - Reliance Orthodontic Products, Light Bond® (Reliance Ortho) | Dental Product | Pearson Dental, RELIANCE LIGHT BOND SEALANT - DynaFlex
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K894565 | Class II | Active |
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Manufacturer
- Manufacturer
- Reliance Orthodontic Products, Inc.
Sources (1)
- FDA 510(k) K894565 24 fields · synced Oct 1, 2026