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EdgeEndo® Gutta Percha Points

by Sure Dent Corporation EUDAMEDGUDID

Active European Union

Ref SGP3006-1

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880926429GP2D Basic UDI-DIDate7 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08800069209350 UDI-DIDate16 Aug 2023ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
EdgeEndo® Gutta Percha Points EUDAMED
Edge .06 GP GUDID
Generic Name
Synthetic gutta-percha
Device Name
Gutta Percha Points
Model / Reference
SGP3006-1
Primary DI / UDI-DI
08800069209350
Basic UDI-DI
880926429GP2D
Direct Marketing DI
08800069209350
FDA Product Code
EKM
EMDN Code
Q01010401 Paper and gutta-percha tips, matrices and wedges for dentistry
GMDN Term
Synthetic gutta-percha
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.3850
Market of Registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I
ImplantableEUDAMED
Yes
GUDID
No

Manufacturer details

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

Other devices from Sure Dent Corporation

See all devices from Sure Dent Corporation →

Properties

  • Single Use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No