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Alpha-Dent Self Cure Bonding Adhesive Kit

EUDAMED

Class IIa (EU MDR)

Ref 200-0000-001

by Dental Technologies, Inc.

Identity

Trade Name
ALPHA-DENT SELF CURE BONDING ADHESIVE KIT EUDAMED
Device Name
Bonding Adhesive EUDAMED
Model / Reference
200-0000-001 EUDAMED

Identifiers

Primary DI / UDI-DI
+D73520000000010 EUDAMED
Basic UDI-DI
++D735BondingAdhesiveYH EUDAMED
EMDN Code
Q01010104 DENTAL BONDING AGENTS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

Yes

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Dentine bonding agent/set

Alpha-Dent Self Cure Bonding Adhesive Kit by Dental Technologies, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dentine bonding agent/set.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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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 2b7b7394-9806-4ec9-848b-f20a51ead291 61 fields · synced Jun 18, 2026