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EndoSequence® Bioceramic Gutta Percha Assortment Wheel

EUDAMED

Class IIa (EU MDR)

Ref 5019507EURef 5019506EURef 5023747EU

by Sure Dent Corporation

Identity

Trade Name
EndoSequence® Bioceramic Gutta Percha Assortment Wheel EUDAMED
Device Name
Gutta Percha Points EUDAMED
Model / Reference
5019507EU EUDAMED
5019506EU EUDAMED
5023747EU EUDAMED

Identifiers

Primary DI / UDI-DI
00887919641087 EUDAMED
00887919641063 EUDAMED
00887919685357 EUDAMED
Basic UDI-DI
880926429GP2D EUDAMED
Direct Marketing DI
00887919641087 EUDAMED
00887919641063 EUDAMED
00887919685357 EUDAMED
EMDN Code
Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY 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

EndoSequence® Bioceramic Gutta Percha Assortment Wheel 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

EUDAMED SRN
KR-MF-000018662
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (3)

  • EUDAMED 9a6b7e70-71ca-4cd7-8140-59ed19562ed5 61 fields · synced Aug 4, 2026
  • EUDAMED 90abe5f6-9423-4da4-a901-0f2aff5327d7 61 fields · synced May 19, 2026
  • EUDAMED 57d1a82d-3c47-45e0-99b6-e32d51243de9 61 fields · synced May 19, 2026