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660.FG.025.ARK

by Jota AG

Ref 635314297505025Model Rotary Instruments

660.FG.025.ARK is a device classified as Class IIa in the EU and Class I in the US made by Jota AG, registered in EUDAMED on 26 Jun 2026 (Basic UDI-DI B-EJOT635314297505025) and listed in FDA GUDID since 15 Sep 2021 (UDI-DI EJOT635314297505025), active as of 24 Oct 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-EJOT635314297505025 Basic UDI-DI EJOT635314297505025UDI-DIDate26 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberEJOT635314297505025 UDI-DI Date15 Sep 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-EJOT635314297505025 registered 26 Jun 2026 Active
  • FDA GUDID UDI-DI EJOT635314297505025 listed 15 Sep 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID EJOT635314297505025
  2. Registered EUDAMED B-EJOT635314297505025

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  • Withdrawn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

Generic name
Dental abrasive point, reusable
Model / reference
Rotary Instruments EUDAMED
635314297505025 EUDAMED
660.FG.025.ARK GUDID
Primary DI / UDI-DI
EJOT635314297505025
Basic UDI-DI
B-EJOT635314297505025
FDA product code
EHL
EMDN code
Q0199 Odontology devices - other
GMDN term
Dental abrasive point, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.6010
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Rotary Instruments
635314297505025
GUDID
660.FG.025.ARK
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Dental abrasive point, reusable

Similar devices in this category

Other devices filed under ODONTOLOGY DEVICES - OTHER.

Other devices from Jota AG

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Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)