Identifiers
- 510(k) Number
- K880793 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)
Light Bond is an adhesive, bracket and tooth conditioner, resin device used in dental applications. It is a light-cure bracket adhesive designed for routine bracket and tube bonding, as well as intraoral bonding of metal, ceramic, or composite attachments.
The device is supplied as a paste and is intended for use by doctors or staff for bracket placement without drift. It is a Class II medical device with FDA 510(k) authorization under K880793, product code DYH, and regulation number 872.3750.
Frequently asked questions
What is Light Bond used for?
Light Bond is a light-cure bracket adhesive designed for routine bracket and tube bonding, as well as intraoral bonding of metal, ceramic, or composite attachments in dental applications.
How is Light Bond supplied and who uses it?
Light Bond is supplied as a paste and is intended for use by doctors or staff for bracket placement without drift during dental procedures.
What regulatory authorization does Light Bond have?
Light Bond is a Class II medical device with FDA 510(k) authorization under K880793, product code DYH, and regulation number 872.3750.
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 Regular Push Syringe Kit with Fluoride | Reliance ..., Reliance Light Bond | US Orthodontic Products
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K880793 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Reliance Orthodontic Products, Inc.
Sources (1)
- FDA 510(k) K880793 24 fields · synced Sep 21, 2026