Identity
- Trade Name
- Rely.a.Bond FDA UDI
- Generic Name
- Orthodontic bracket adhesive FDA UDI
- Device Name
- Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic brackets. Kit contains 14g Thin Viscosity Rely A Bond Adhesive Paste in push Syringes, 16g Primer with fluoride, liquid etchant 9g, mixing pad, spatulas and brushes. Thin Viscosity Kit with Fluoride. FDA UDI
- Model / Reference
- RPTHINF FDA UDI
- Description
- Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic brackets. Kit contains 14g Thin Viscosity Rely A Bond Adhesive Paste in push Syringes, 16g Primer with fluoride, liquid etchant 9g, mixing pad, spatulas and brushes. Thin Viscosity Kit with Fluoride. FDA UDI
Identifiers
- Catalog Number
- RPTHINF FDA UDI
- Primary DI / UDI-DI
- D798RPTHINF0 FDA UDI
- 510(k) Number
- K895521 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
- Not 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
Yes
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
Rely.a.Bond by Reliance Orthodontic Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K895521 also covers:
- RELY A BOND PASTE 3.5 GM SYRINGE — FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC.
- Rely a Bond — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Rely a Bond — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Rely a Bond — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Rely.a.Bond — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Rely.a.Bond — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Rely.a.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 4f6c0b9f-13b8-454a-97d5-51d139857226 38 fields · synced May 30, 2026