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SoftFlow SF-W

by DENTOS Inc.

Ref SF-W

SoftFlow SF-W is a Class I device made by DENTOS Inc., registered in EUDAMED on 22 Aug 2022 (Basic UDI-DI 88061454SF001KR) and listed in FDA GUDID since 27 Feb 2019 (UDI-DI 08806145484031), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88061454SF001KR Basic UDI-DI 08806145484031UDI-DIDate22 Aug 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number08806145484031 UDI-DI Date27 Feb 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88061454SF001KR registered 22 Aug 2022 Active
  • FDA GUDID UDI-DI 08806145484031 listed 27 Feb 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08806145484031
  2. Registered EUDAMED 88061454SF001KR

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
SoftFlow
Generic name
Orthodontic appliance relief material
Model / reference
SF-W
Primary DI / UDI-DI
08806145484031
Basic UDI-DI
88061454SF001KR
Unit of use DI
08806145484871
FDA product code
EGD
EMDN code
Q010499 Orthodontic devices - other
GMDN term
Orthodontic appliance relief material
Device class
Class I
Regulation number
872.6890
EU registration type
Standard device
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthodontic appliance relief material

Similar devices in this category

Other devices filed under ORTHODONTIC DEVICES - OTHER.

Other devices from DENTOS Inc.

See all devices from DENTOS Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)