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Bonding agents for fixed orthodontic appliance

EUDAMED

Class IIa (EU MDR)

Ref E3163-00

by Leone S.p.a.

Identity

Device Name
Bonding agents for fixed orthodontic appliance EUDAMED
Model / Reference
E3163-00 EUDAMED

Identifiers

Primary DI / UDI-DI
08033707024569 EUDAMED
Basic UDI-DI
B-08033707024569 EUDAMED
EMDN Code
Q01010104 DENTAL BONDING AGENTS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Italy EUDAMED

Clinical & Handling

Sterile

No

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

Bonding agents for fixed orthodontic appliance by Leone S.p.a. — 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
Leone S.p.a.
EUDAMED SRN
IT-MF-000005986

Sources (1)

  • EUDAMED 0b343306-94b4-4a96-bbfc-b0893a325ae6 61 fields · synced Jun 19, 2026