Identity
- Trade Name
- ALPHA-DENT® Self Cure Bracket Bonding Resin FDA UDI
- Generic Name
- Dentine bonding agent/set FDA UDI
- Device Name
- ALPHA-DENT® Self Cure Bracket Bonding Resin is a self cure two paste system formulated to bond to metal, ceramic and plastic brackets. The unique filler combination used in the pastes produces a superior bond when used with Self Cure Bracket Bonding Resin and minimized bond failures. Kit Contains: 1 x 7ml Bracket Bonding Base FDA UDI
- Model / Reference
- 210.0101.001 FDA UDI
- Description
- ALPHA-DENT® Self Cure Bracket Bonding Resin is a self cure two paste system formulated to bond to metal, ceramic and plastic brackets. The unique filler combination used in the pastes produces a superior bond when used with Self Cure Bracket Bonding Resin and minimized bond failures. Kit Contains: 1 x 7ml Bracket Bonding Base FDA UDI
Identifiers
- Catalog Number
- 210.0101.001 FDA UDI
- Primary DI / UDI-DI
- D73521001010010 FDA UDI
- 510(k) Number
- K930614 FDA UDI
- FDA Product Code
- DYH FDA UDI
- GMDN Term
- Dentine bonding agent/set 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: Dentine bonding agent/set
ALPHA-DENT® Self Cure Bracket Bonding Resin by Dental Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dentine bonding agent/set.
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- 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
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Cleared under the same submission
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 63ee69cd-f3d8-4853-b75c-58143df6d7f0 37 fields · synced Jun 9, 2026