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CrownTaper GuttaPercha Points

EUDAMED

Class IIa (EU MDR)

Ref 122F3Ref 122F1Ref 122F2Ref 122F5

by Sure Dent Corporation

Identity

Trade Name
CrownTaper GuttaPercha Points EUDAMED
Device Name
Gutta Percha Points EUDAMED
Model / Reference
122F3 EUDAMED
122F1 EUDAMED
122F2 EUDAMED
122F5 EUDAMED

Identifiers

Primary DI / UDI-DI
08800069211100 EUDAMED
08800069211087 EUDAMED
08800069211094 EUDAMED
08800069211124 EUDAMED
Basic UDI-DI
880926429GP2D EUDAMED
Direct Marketing DI
08800069211100 EUDAMED
08800069211087 EUDAMED
08800069211094 EUDAMED
08800069211124 EUDAMED
EMDN Code
Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Sweden 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

CrownTaper GuttaPercha Points by Sure Dent Corporation — 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

Manufacturer
Sure Dent Corporation
EUDAMED SRN
KR-MF-000018662
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (4)

  • EUDAMED 9e081159-0355-4fb0-ae85-547d2bb6b843 61 fields · synced Jul 17, 2026
  • EUDAMED 396493c6-88e5-4eb6-baf8-158975e690c2 61 fields · synced May 17, 2026
  • EUDAMED 3a0d24fb-fe48-4d06-8b9d-10c2a44fcd70 61 fields · synced May 17, 2026
  • EUDAMED ae4f1264-3400-4b41-a726-63f06af2a68c 61 fields · synced May 18, 2026