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Create A3

by ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk

Model A1, A2, A3, A3.5 , B1, B2, C2, D2, D3, T, OA2, OA3

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number590443371TF0067G Basic UDI-DI Date10 Feb 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Trade Name
Create A3
Create A3.5
Device Name
Create/ Boston
Model / Reference
A1, A2, A3, A3.5, B1, B2, C2, D2, D3, T, OA2, OA3
Primary DI / UDI-DI
05903678494216, 05903678494223
Basic UDI-DI
590443371TF0067G
EMDN Code
Q01010103 Dental restorative composites
Device Class
Class IIa
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000029550

Related devices

Category: Dental composite resin

Other devices from ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk

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Properties

  • Implantable

Other properties (12)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No