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ALPHA BOND SE SELF ETCH LIGHT CURE BONDING AGENT 5ml BOTTLE

EUDAMED

Class IIa (EU MDR)

Ref 211-0401-002

by Dental Technologies, Inc.

Identity

Trade Name
ALPHA BOND SE SELF ETCH LIGHT CURE BONDING AGENT 5ml BOTTLE EUDAMED
Device Name
Bonding Adhesive EUDAMED
Model / Reference
211-0401-002 EUDAMED

Identifiers

Primary DI / UDI-DI
+D73521104010020 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

ALPHA BOND SE SELF ETCH LIGHT CURE BONDING AGENT 5ml BOTTLE by Dental Technologies, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
US-MF-000027130
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (1)

  • EUDAMED 627d909e-d8ed-4a8b-b0e6-55a25b85e222 61 fields · synced Jul 16, 2026