Alpha-Dent Light Cure Hybrid Composite 2 Syringe Kit W/ Liquid Etchant (custom)

EUDAMED

Class IIa (EU MDR)

Ref 101-0008-001

by Dental Technologies, Inc.

Identity

Trade Name: ALPHA-DENT LIGHT CURE HYBRID COMPOSITE 2 SYRINGE KIT W/ LIQUID ETCHANT (CUSTOM) EUDAMED
Device Name: Restorative Composite EUDAMED
Model / Reference: 101-0008-001 EUDAMED

Identifiers

Primary DI / UDI-DI: +D73510100080010 EUDAMED
Basic UDI-DI: ++D735CompositeP6 EUDAMED
EMDN Code: Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Poland EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

Yes

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Alpha-Dent Light Cure Hybrid Composite 2 Syringe Kit W/ Liquid Etchant (custom) by Dental Technologies, Inc. — Class IIa — MDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	++D735CompositeP6	Class IIa	Active

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Manufacturer

Manufacturer: Dental Technologies, Inc.
EUDAMED SRN: US-MF-000027130
Authorised Representative: Emergo Europe B.V. NL-AR-000000116

Sources (1)

EUDAMED 63a3c7dc-e7a9-4cfc-84cf-0bc5f1cca326 61 fields · synced Aug 4, 2026