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Well-Root ST WR102-K00E

by Vericom Co., Ltd.

Ref WR102-K00E

Well-Root ST WR102-K00E is an endodontic filling/sealing material (EU MDD Class IIa; FDA Class II; FDA product code KIF, Resin, Root Canal Filling) made by Vericom Co., Ltd., registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI B-08809254458139) and listed in FDA GUDID since 18 Oct 2018 (UDI-DI 08809254458139), active as of 7 Nov 2026.

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

CE MDD

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809254458139 Basic UDI-DI 08809254458139UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809254458139 UDI-DI Date18 Oct 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08809254458139 registered 5 Nov 2026 Active
  • FDA GUDID UDI-DI 08809254458139 listed 18 Oct 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08809254458139
  2. Registered EUDAMED B-08809254458139

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Well-Root ST
Generic name
Endodontic filling/sealing material
Device name
Dental root canal sealing material
Model / reference
WR102-K00E
Primary DI / UDI-DI
08809254458139
Basic UDI-DI
B-08809254458139
FDA product code
KIF
EMDN code
Q01010201 Root canal filling dental pastes
GMDN term
Endodontic filling/sealing material
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3820
EU registration type
Legacy device (under a directive)
EU 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 II
ImplantableEUDAMED
Yes
GUDID
No

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

Related devices

Category: Endodontic filling/sealing material

Similar devices in this category

Other devices filed under ROOT CANAL FILLING DENTAL PASTES.

Other devices from Vericom Co., Ltd.

See all devices from Vericom Co., Ltd. →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)