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Dental Bonding Agent

EUDAMED

Class IIa (EU MDR)

Ref Dental Bonding Agent

by AT&M Biomaterials Co., Ltd.

Identity

Trade Name
Dental Bonding Agent EUDAMED
Device Name
Dental Bonding Agent EUDAMED
Model / Reference
Dental Bonding Agent EUDAMED

Identifiers

Primary DI / UDI-DI
06935546103011 EUDAMED
Basic UDI-DI
B-06935546103011 EUDAMED
EMDN Code
Q01010104 DENTAL BONDING AGENTS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Poland EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Dentine bonding agent/set

Dental Bonding Agent by AT&M Biomaterials Co., Ltd. — Class IIa — MDD — 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/MDD

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Manufacturer

Manufacturer
AT&M Biomaterials Co., Ltd.
EUDAMED SRN
CN-MF-000010556
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (1)

  • EUDAMED a9641f53-ad49-460e-9e40-b2c97c9aa4c2 61 fields · synced Jul 17, 2026