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Nanohybrid Composite+ Capsules B2

EUDAMED

Class IIa (EU MDR)

Ref 3136598

by Spident

Identity

Trade Name
Nanohybrid Composite+ Capsules B2 EUDAMED
Device Name
EsCom100 EUDAMED
Model / Reference
3136598 EUDAMED

Identifiers

Primary DI / UDI-DI
08809911117362 EUDAMED
Basic UDI-DI
880926295EFZP EUDAMED
Direct Marketing DI
08809911117362 EUDAMED
EMDN Code
Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
France 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: Dental composite resin

Nanohybrid Composite+ Capsules B2 by Spident — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dental composite resin.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Spident
EUDAMED SRN
KR-MF-000008691
Authorised Representative
AR Experts B.V. NL-AR-000023989

Sources (1)

  • EUDAMED a543fcaa-8bf8-49a8-986b-06e5d9ea78f8 61 fields · synced Jul 26, 2026