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Smartcord 03

by EASTDENT Co., Ltd

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

Ref EDSC-AModel Smartcord

Smartcord 03 (EDSC-A) 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 08809370410059), 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 linked in EUDAMED

A group certificate may exist

510(k) K171577↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08809370410059 UDI-DI Date1 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number880937041001177 Basic UDI-DI 08809370410059UDI-DIDate29 Apr 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) 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 08809370410059 listed 1 Oct 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K171577
  2. Registered EUDAMED 880937041001177
  3. Listed FDA GUDID 08809370410059

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade name
Smartcord 03 EUDAMED
Smartcord GUDID
Generic name
Gingival retraction cord, non-medicated
Device name
Gingival Retraction Cord
Model / reference
Smartcord EUDAMED
EDSC-A EUDAMED
03 GUDID
Primary DI / UDI-DI
08809370410059
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-A
GUDID
03
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)