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Sure-Cord Plus

by Sure Dent Corporation 12 variants

Part of a family of 12 devices: see the family page

Ref SCP-2

Sure-Cord Plus (SCP-2) is a gingival retraction cord (EU MDR Class IIa; FDA unclassified; FDA product code MVL, Cord, Retraction) made by Sure Dent Corporation, registered in EUDAMED on 9 Apr 2026 (Basic UDI-DI 880926429CPZW), cleared under FDA 510(k) K132526 on 26 Nov 2013 and listed in FDA GUDID since 6 Nov 2023 (UDI-DI 08809264299463), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K132526

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880926429CPZW Basic UDI-DI 08809264299463UDI-DIDate9 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809264299463 UDI-DI Date6 Nov 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK132526 Date26 Nov 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 880926429CPZW registered 9 Apr 2026 Active
  • FDA 510(k) K132526 decided 26 Nov 2013 Active
  • FDA GUDID UDI-DI 08809264299463 listed 6 Nov 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K132526
  2. Listed FDA GUDID 08809264299463
  3. Registered EUDAMED 880926429CPZW

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Sure-Cord Plus EUDAMED
Sure-endo GUDID
Generic name
Gingival retraction cord, medicated
Device name
Impregnated Retraction Cord
Model / reference
SCP-2
Primary DI / UDI-DI
08809264299463
Basic UDI-DI
880926429CPZW
Direct marketing DI
08809264299463
510(k) Number
FDA product code
MVL
EMDN code
Q010204 Retraction wires and gingival retractors
GMDN term
Gingival retraction cord, medicated
Device class
Class IIa EUDAMED
U GUDID
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
U

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), U in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

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

Related devices

Category: Gingival retraction cord, non-medicated

Similar devices in this category

Other devices filed under RETRACTION WIRES AND GINGIVAL RETRACTORS.

Other devices from Sure Dent Corporation

See all devices from Sure Dent Corporation →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)