Identity
- Trade Name
- Excel FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Excel is intended for use as an orthodontic bonding adhesive for appliances. This Kit contains 2 X 6g Excel regular paste B in screw syringes , 2 X 6g ea. Excel Regular paste A in screw syringes, 1 X 7g. Bonding resin A, 1 X 7g Bonding Resin B , 1 X Etch (liquid 9g). and 1 X 10cc Plastic Conditioner . This kit contains fluoride. FDA UDI
- Model / Reference
- EHSF FDA UDI
- Description
- Excel is intended for use as an orthodontic bonding adhesive for appliances. This Kit contains 2 X 6g Excel regular paste B in screw syringes , 2 X 6g ea. Excel Regular paste A in screw syringes, 1 X 7g. Bonding resin A, 1 X 7g Bonding Resin B , 1 X Etch (liquid 9g). and 1 X 10cc Plastic Conditioner . This kit contains fluoride. FDA UDI
Identifiers
- Catalog Number
- EHSF FDA UDI
- Primary DI / UDI-DI
- D798EHSF0 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental composite resinOrthodontic bracket adhesive
Excel by Reliance Orthodontic Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic bracket adhesive.
- Opal Bond — ULTRADENT PRODUCTS, INC. · Class I
- ORTHOSOURCE — Ortho Source
- Resilience — ORTHO TECHNOLOGY, INC. · Class II
- Illuminate — Ortho Organizers, Inc. · Class II
- Novocol GRANITEC PRIMER 9ML — Septodont · Class II
- ORTHOSOURCE — Ortho Source · Class II
- OrthoFlow® — Six Month Smiles · Class II
- ALPHA-DENT® Paste & Paste Orthodontic Adhesive — Dental Technologies, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Reliance Orthodontic Products, Inc.
Sources (1)
- FDA UDI d9fc6510-742e-478a-95ef-11b9b0dd82fe 37 fields · synced May 30, 2026