Identity
- Trade Name
- Alpha-Bond® SE FDA UDI
- Generic Name
- Dentine bonding agent/set FDA UDI
- Device Name
- Alpha-Bond® SE is a 7th generation self-etch adhesive formulated to bond to multiple substrates for both direct and indirect bonding procedures. It's a universal adhesive that has the bond strength and durability of a total-etch adhesive while eliminating the etching step. Kit Contains: 1 x 5ml Bottle FDA UDI
- Model / Reference
- 211.0401.002 FDA UDI
- Description
- Alpha-Bond® SE is a 7th generation self-etch adhesive formulated to bond to multiple substrates for both direct and indirect bonding procedures. It's a universal adhesive that has the bond strength and durability of a total-etch adhesive while eliminating the etching step. Kit Contains: 1 x 5ml Bottle FDA UDI
Identifiers
- Catalog Number
- 211.0401.002 FDA UDI
- Primary DI / UDI-DI
- D73521104010020 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-Bond® SE by Dental Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K984503 also covers:
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- 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® 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.
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- Alpha-Bond® — Dental Technologies, Inc.
- Alpha-Bond® Activator — 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 b467dae2-070b-4105-842d-cbc93e81aae5 37 fields · synced Jun 9, 2026