Identity
- Trade Name
- ALPHA-DENT® Light Cure Bracket Adhesive FDA UDI
- Generic Name
- Orthodontic bracket adhesive FDA UDI
- Device Name
- ALPHA-DENT® Light Cure Bracket Adhesive is a Paste-Adhesive system formulated to bond to metal, ceramic, and plastic brackets. The unique filler combination used in the paste produces an ideal bond and a smooth tacky consistency minimizing bracket floatation. By using light cure adhesive technology we have eliminated working time contraints. Kit Contains: 1 x 5g Adhesive Syringe FDA UDI
- Model / Reference
- 303.0202.001 FDA UDI
- Description
- ALPHA-DENT® Light Cure Bracket Adhesive is a Paste-Adhesive system formulated to bond to metal, ceramic, and plastic brackets. The unique filler combination used in the paste produces an ideal bond and a smooth tacky consistency minimizing bracket floatation. By using light cure adhesive technology we have eliminated working time contraints. Kit Contains: 1 x 5g Adhesive Syringe FDA UDI
Identifiers
- Catalog Number
- 303.0202.001 FDA UDI
- Primary DI / UDI-DI
- D73530302020010 FDA UDI
- 510(k) Number
- K935625 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
ALPHA-DENT® Light Cure Bracket Adhesive by Dental Technologies, 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
- Light Bond — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
- Light Cure Retainer — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
- Rely a Bond — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
Cleared under the same submission
K935625 also covers:
- ALPHA-DENT® Light Cure Bracket Adhesive — Dental Technologies, Inc.
- ALPHA-DENT® Light Cure Bracket Adhesive — Dental Technologies, Inc.
- ALPHA-DENT® Light Cure Bracket Adhesive — Dental Technologies, Inc.
- ALPHA-DENT® Light Cure Bracket Adhesive — Dental Technologies, Inc.
- ALPHA-DENT® Light Cure Bracket Bonding Resin — Dental Technologies, Inc.
- ALPHA-DENT® Light Cure Bracket Bonding Resin — Dental Technologies, Inc.
- ORAPRO — ORTHOQUEST, INC.
- ORAPRO — ORTHOQUEST, INC.
- ORAPRO — ORTHOQUEST, INC.
- ORAPRO — ORTHOQUEST, INC.
- ORAPRO — ORTHOQUEST, INC.
- Illuminate — Ortho Organizers, 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
- Dental Technologies, Inc.
Sources (1)
- FDA UDI 48bcd382-c9b9-46e9-994b-86eb1c8cf36c 37 fields · synced Jun 9, 2026