Alpha-Dent® Light Cure Hybrid Composite

FDA UDI

Class II (US FDA UDI)

by Dental Technologies, Inc.

Identity

Trade Name: ALPHA-DENT® LIGHT CURE HYBRID COMPOSITE FDA UDI
Generic Name: Dental composite resin FDA UDI
Device Name: ALPHA-DENT® Light Cure Composite restorative is radiopaque. It has the versatility of the Hybrid composite while measuring high compressive strength with excellent polishablity. The composite is appropriate for almost every type restoration. Kit contains: 7 x 4.5g Composite Syringes, 3ml Light Cure Bonding Resin, 7ml Etchant Liquid, Brushes, Brush Holder, Dispensing Pad FDA UDI
Model / Reference: 101.0000.001 FDA UDI
Description: ALPHA-DENT® Light Cure Composite restorative is radiopaque. It has the versatility of the Hybrid composite while measuring high compressive strength with excellent polishablity. The composite is appropriate for almost every type restoration. Kit contains: 7 x 4.5g Composite Syringes, 3ml Light Cure Bonding Resin, 7ml Etchant Liquid, Brushes, Brush Holder, Dispensing Pad FDA UDI

Identifiers

Catalog Number: 101.0000.001 FDA UDI
Primary DI / UDI-DI: D73510100000010 FDA UDI
510(k) Number: K904813 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-Dent® Light Cure Hybrid Composite 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

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 958d4264-5971-42e7-a956-86373ece04f4 37 fields · synced Jun 9, 2026