Identity
- Trade Name
- Light Bond FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Light Bond™ sealants are intended for use as a light cure sealant resin for bonding under an orthodontic adhesive. These are Filled Sealant Resin in a 7cc bottle. This product contains Fluoride. FDA UDI
- Model / Reference
- LBFS7F FDA UDI
- Description
- Light Bond™ sealants are intended for use as a light cure sealant resin for bonding under an orthodontic adhesive. These are Filled Sealant Resin in a 7cc bottle. This product contains Fluoride. FDA UDI
Identifiers
- Catalog Number
- LBFS7F FDA UDI
- Primary DI / UDI-DI
- D798LBFS7F0 FDA UDI
- 510(k) Number
- K895522 FDA UDI
- FDA Product Code
- DYH FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental composite resin
Light Bond by Reliance Orthodontic Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental composite resin.
- Name: Light Curing Composite Model: Flow — Micerium S.p.A. · Class IIa
- Forma S — ULTRADENT PRODUCTS, INC. · Class II
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- Bright Flow Core DC 5ml Dentine — DMP Dental Industry S.A. · Class IIa
- Llis — Dentscare Ltda · Class II
- Capo Universal, 6 g — Schütz Dental GmbH · Class II
- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
Cleared under the same submission
K895522 also covers:
- Assure — RELIANCE ORTHODONTIC PRODUCTS, INC.
- LIGHT BOND — RELIANCE ORTHODONTIC PRODUCTS, INC.
- LIGHT BOND — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Light Bond — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Light Bond — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Light Bond — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Light Bond — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Light Bond — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Light Bond — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Light Bond — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Light Bond — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Light Bond — RELIANCE ORTHODONTIC PRODUCTS, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Reliance Orthodontic Products, Inc.
Sources (1)
- FDA UDI b8aca0bd-6c83-4dc3-aa48-95c480ceda69 37 fields · synced May 31, 2026