Identity
- Trade Name
- Excel FDA UDI
- Generic Name
- Orthodontic bracket adhesive FDA UDI
- Device Name
- Excel is intended for use as an orthodontic bonding adhesive for appliances. This Excel Regular Blue Kit contains 12g Excel Regular Blue paste A with fluoride in jar, 12g Excel Regular paste B in jar, 1 X 7cc Bonding Resin A with Fluoride, 1 X 7cc Bonding Resin B, 1 X 9g Etchant Liquid and mixing accessories. This product contains fluoride. FDA UDI
- Model / Reference
- ERBJF FDA UDI
- Description
- Excel is intended for use as an orthodontic bonding adhesive for appliances. This Excel Regular Blue Kit contains 12g Excel Regular Blue paste A with fluoride in jar, 12g Excel Regular paste B in jar, 1 X 7cc Bonding Resin A with Fluoride, 1 X 7cc Bonding Resin B, 1 X 9g Etchant Liquid and mixing accessories. This product contains fluoride. FDA UDI
Identifiers
- Catalog Number
- ERBJF FDA UDI
- Primary DI / UDI-DI
- D798ERBJF0 FDA UDI
- 510(k) Number
- K875141 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
Excel by Reliance Orthodontic Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K875141 also covers:
- EXCEL — RELIANCE ORTHODONTIC PRODUCTS, INC.
- EXCEL — RELIANCE ORTHODONTIC PRODUCTS, INC.
- EXCEL — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Excel — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Excel — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Excel — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Excel — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Excel — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Excel — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Excel — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Excel — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Excel — 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 782139bc-6173-4781-a1b8-1f0cb01a11d6 38 fields · synced May 30, 2026