Identity
- Trade Name
- ALPHA-DENT® Light Cure Bonding Adhesive FDA UDI
- Generic Name
- Dentine bonding agent/set FDA UDI
- Device Name
- ALPHA-DENT® Light Cure Bonding Adhesive is designed for bonding composite resin materials to dentin and enamel. The ideal viscosity allows the material to penetrate into microtubules to enhance mechanical adhesion. Kit Contains: 1 x 3ml Bonding Resin Bottle FDA UDI
- Model / Reference
- 206.0101.001 FDA UDI
- Description
- ALPHA-DENT® Light Cure Bonding Adhesive is designed for bonding composite resin materials to dentin and enamel. The ideal viscosity allows the material to penetrate into microtubules to enhance mechanical adhesion. Kit Contains: 1 x 3ml Bonding Resin Bottle FDA UDI
Identifiers
- Catalog Number
- 206.0101.001 FDA UDI
- Primary DI / UDI-DI
- D73520601010010 FDA UDI
- 510(k) Number
- K984503 FDA UDI
- FDA Product Code
- KLE FDA UDI
- GMDN Term
- Dentine bonding agent/set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3200 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: Dentine bonding agent/set
ALPHA-DENT® Light Cure Bonding Adhesive by Dental Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dentine bonding agent/set.
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
Cleared under the same submission
K984503 also covers:
- ALPHA-DENT® Etchant Liquid — Dental Technologies, Inc.
- ALPHA-DENT® Etchant Liquid — Dental Technologies, Inc.
- ALPHA-DENT® Etchant Liquid — Dental Technologies, Inc.
- ALPHA-DENT® Etchant Liquid — Dental Technologies, Inc.
- ALPHA-DENT® Light Cure Bonding Adhesive — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Bonding Adhesive — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Bonding Adhesive — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Bonding Adhesive — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Bonding Adhesive — Dental Technologies, Inc.
- Alpha-Bond® — Dental Technologies, Inc.
- Alpha-Bond® Activator — Dental Technologies, Inc.
- Alpha-Bond® SE — Dental Technologies, 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
- Dental Technologies, Inc.
Sources (1)
- FDA UDI c9f8fdee-8752-4bfc-85a3-73148ba81ed3 37 fields · synced Jun 9, 2026