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Jota 845.FG.010

by Jota AG

Ref 806314168524010Model Rotary Instruments

Jota 845.FG.010 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-EJOT806314168524010) and listed in FDA GUDID since 24 Jan 2024 (UDI-DI EJOT806314168524010), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-EJOT806314168524010 Basic UDI-DI EJOT806314168524010UDI-DIDate26 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberEJOT806314168524010 UDI-DI Date24 Jan 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-EJOT806314168524010 registered 26 Jun 2026 Active
  • FDA GUDID UDI-DI EJOT806314168524010 listed 24 Jan 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID EJOT806314168524010
  2. Registered EUDAMED B-EJOT806314168524010

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  • Withdrawn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
Jota
Generic name
Diamond dental bur, reusable
Model / reference
Rotary Instruments EUDAMED
806314168524010 EUDAMED
845.FG.010 GUDID
Primary DI / UDI-DI
EJOT806314168524010
Basic UDI-DI
B-EJOT806314168524010
FDA product code
DZP
EMDN code
Q0199 Odontology devices - other
GMDN term
Diamond dental bur, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.4535
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
806314168524010
GUDID
845.FG.010
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: Diamond 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
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)