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Smartcord 2

by EASTDENT Co., Ltd

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

Ref EDSC-EModel Smartcord

Smartcord 2 (EDSC-E) is a gingival retraction cord (EU MDR Class I; FDA unclassified; FDA product code MVL, Cord, Retraction) made by Eastdent Co., Ltd, registered in EUDAMED on 29 Apr 2026 (Basic UDI-DI 880937041001177), cleared under FDA 510(k) K171577 on 3 May 2018 and listed in FDA GUDID since 1 Oct 2026 (UDI-DI 08809370410097), active as of 23 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 23 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K171577

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08809370410097 UDI-DI Date1 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number880937041001177 Basic UDI-DI 08809370410097UDI-DIDate29 Apr 2026RegisteredStatusActive
United StatesFDA 510(k) GUDID from GUDID NumberK171577 Date3 May 2018IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 880937041001177 registered 29 Apr 2026 Active
  • FDA 510(k) K171577 decided 3 May 2018 Active
  • FDA GUDID UDI-DI 08809370410097 listed 1 Oct 2026 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K171577
  2. Registered EUDAMED 880937041001177
  3. Listed FDA GUDID 08809370410097

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  • Withdrawn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
Smartcord 2 EUDAMED
Smartcord GUDID
Generic name
Gingival retraction cord, non-medicated
Device name
Gingival Retraction Cord
Model / reference
Smartcord EUDAMED
EDSC-E EUDAMED
2 GUDID
Primary DI / UDI-DI
08809370410097
Basic UDI-DI
880937041001177
510(k) Number
FDA product code
MVL
EMDN code
Q010204 Retraction wires and gingival retractors
GMDN term
Gingival retraction cord, non-medicated
Device class
Class I EUDAMED
U GUDID
EU registration type
Standard device
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Smartcord
EDSC-E
GUDID
2
Device classEUDAMED
Class I
GUDID
U

Device class is stated on each registry's own scale: Class I 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-000022583
Authorised representative
KTR Europe GmbH DE-AR-000005685

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 Eastdent Co., Ltd

See all devices from Eastdent Co., Ltd →

Properties

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