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C21.FG.008

by Jota AG

Ref 500314107006008Model Rotary Instruments

C21.FG.008 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-EJOT500314107006008) and listed in FDA GUDID since 15 Sep 2021 (UDI-DI EJOT500314107006008), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-EJOT500314107006008 Basic UDI-DI EJOT500314107006008UDI-DIDate26 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberEJOT500314107006008 UDI-DI Date15 Sep 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-EJOT500314107006008 registered 26 Jun 2026 Active
  • FDA GUDID UDI-DI EJOT500314107006008 listed 15 Sep 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID EJOT500314107006008
  2. Registered EUDAMED B-EJOT500314107006008

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  • Withdrawn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
Carbide dental bur, reusable
Model / reference
Rotary Instruments EUDAMED
500314107006008 EUDAMED
C21.FG.008 GUDID
Primary DI / UDI-DI
EJOT500314107006008
Basic UDI-DI
B-EJOT500314107006008
FDA product code
EKD
EMDN code
Q0199 Odontology devices - other
GMDN term
Carbide dental bur, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.4565
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
500314107006008
GUDID
C21.FG.008
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: Carbide dental bur, reusable

Similar devices in this category

Other devices filed under ODONTOLOGY DEVICES - OTHER.

Other devices from Jota AG

See all devices from Jota AG →

Properties

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