Identity
- Trade Name
- Assure FDA UDI
- Generic Name
- Orthodontic bracket adhesive FDA UDI
- Device Name
- Assure paste is intended for use as light cure, hydrophilic bracket adhesive, therefore it can be applied to a dry or slightly contaminated surface. The smooth cohesive paste viscosity allows for easy application to any style bracket base insuring maximum mechanical retention. FDA UDI
- Model / Reference
- APP FDA UDI
- Description
- Assure paste is intended for use as light cure, hydrophilic bracket adhesive, therefore it can be applied to a dry or slightly contaminated surface. The smooth cohesive paste viscosity allows for easy application to any style bracket base insuring maximum mechanical retention. FDA UDI
Identifiers
- Catalog Number
- APP FDA UDI
- Primary DI / UDI-DI
- D798APP0 FDA UDI
- 510(k) Number
- K895522 FDA UDI
- FDA Product Code
- DYH FDA UDI
- GMDN Term
- Orthodontic bracket adhesive 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: Orthodontic bracket adhesive
Assure by Reliance Orthodontic Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ALPHA-DENT® Paste & Paste Orthodontic Adhesive — Dental Technologies, Inc.
Cleared under the same submission
K895522 also covers:
- 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.
- 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 |
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Manufacturer
- Manufacturer
- Reliance Orthodontic Products, Inc.
Sources (1)
- FDA UDI ad7c26b4-1cf2-4435-ad25-b3a900aa9a24 37 fields · synced May 30, 2026