Alpha-Core® SC

FDA UDI

Class II (US FDA UDI)

by Dental Technologies, Inc.

Identity

Trade Name: Alpha-Core® SC FDA UDI
Generic Name: Dental composite resin FDA UDI
Device Name: Alpha-Core® SC is a self cure composite specifically designed for core build ups and cementations 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 the materials to be placed with a syringe and depending on the shade of the base paste, it can be used to match or contract the color. Kit Contains: 14g Catalyst, 14g Base (White), Spatulas, Mixing Pads FDA UDI
Model / Reference: 120.0025.002 FDA UDI
Description: Alpha-Core® SC is a self cure composite specifically designed for core build ups and cementations 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 the materials to be placed with a syringe and depending on the shade of the base paste, it can be used to match or contract the color. Kit Contains: 14g Catalyst, 14g Base (White), Spatulas, Mixing Pads FDA UDI

Identifiers

Catalog Number: 120.0025.002 FDA UDI
Primary DI / UDI-DI: D73512000250020 FDA UDI
510(k) Number: K932827 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental composite resin

Alpha-Core® SC by Dental Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

K932827 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

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Manufacturer

Manufacturer: Dental Technologies, Inc.

Sources (1)

FDA UDI e797d4d4-0144-4987-8c9a-4f2a8416d4b7 37 fields · synced Jun 9, 2026