Identity
- Trade Name
- Alpha-Core® DC FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Alpha-Core® DC is a highly filled radiopaque, dual cure composite in an Automix Delivery System designed specially for core build-ups and cementation of posts and pins. The material exhibits ideal mechanical properties with high compressive and tensile strength yet maintaining a dentin like feel when cutting. Its ideal handling characteristics allows for direct placement of that material with Intra Oral Tips. Kit Contains: 50g Cartridge (Shade A2), 10 Automix Tips, 10 Intra Oral Tips FDA UDI
- Model / Reference
- 122.0003.002 FDA UDI
- Description
- Alpha-Core® DC is a highly filled radiopaque, dual cure composite in an Automix Delivery System designed specially for core build-ups and cementation of posts and pins. The material exhibits ideal mechanical properties with high compressive and tensile strength yet maintaining a dentin like feel when cutting. Its ideal handling characteristics allows for direct placement of that material with Intra Oral Tips. Kit Contains: 50g Cartridge (Shade A2), 10 Automix Tips, 10 Intra Oral Tips FDA UDI
Identifiers
- Catalog Number
- 122.0003.002 FDA UDI
- Primary DI / UDI-DI
- D73512200030020 FDA UDI
- 510(k) Number
- K070191 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-Core® DC 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
K070191 also covers:
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 534f2fc0-7bc0-4ca9-b960-6e00da8d6fe1 37 fields · synced Jun 9, 2026