Identity
- Trade Name
- ALPHA-DENT® Self Cure Composite FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- ALPHA-DENT® Self Cure Composite contains 63% by volume of a blend of radiopaque fillers. With its ideal mechanical properties exhibiting high compressive strength and low water sorption, it has become a best seller in its category. Available in one universal shade that blends well to the existing tooth structure yielding an esthetically pleasing restoration. Kit Contains: 14g Catalyst Paste, 14g Base Paste, Spatulas, Bonding Resin, Etchant Gel, Spatulas, Mixing Pads FDA UDI
- Model / Reference
- 110.0003.001 FDA UDI
- Description
- ALPHA-DENT® Self Cure Composite contains 63% by volume of a blend of radiopaque fillers. With its ideal mechanical properties exhibiting high compressive strength and low water sorption, it has become a best seller in its category. Available in one universal shade that blends well to the existing tooth structure yielding an esthetically pleasing restoration. Kit Contains: 14g Catalyst Paste, 14g Base Paste, Spatulas, Bonding Resin, Etchant Gel, Spatulas, Mixing Pads FDA UDI
Identifiers
- Catalog Number
- 110.0003.001 FDA UDI
- Primary DI / UDI-DI
- D73511000030010 FDA UDI
- 510(k) Number
- K904812 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental composite resin
ALPHA-DENT® Self Cure Composite by Dental Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental composite resin.
- Name: Light Curing Composite Model: Flow — Micerium S.p.A. · Class IIa
- Forma S — ULTRADENT PRODUCTS, INC. · Class II
- NovaPro Fill — NANOVA BIOMATERIALS INC · Class II
- SimpliShade — KERR CORPORATION · Class II
- Bright Flow Core DC 5ml Dentine — DMP Dental Industry S.A. · Class IIa
- Llis — Dentscare Ltda · Class II
- Capo Universal, 6 g — Schütz Dental GmbH · Class II
- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
Cleared under the same submission
K904812 also covers:
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
- ALPHA-DENT® Self Cure Composite — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Composite — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Composite — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Composite — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Composite — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Composite — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Composite — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Composite — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Composite — 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 0ddba878-d50a-474a-8175-134d580da5df 37 fields · synced Jun 9, 2026