Skip to content

Jota 9828.RA.040

by Jota AG

Ref 803204243525040Model Rotary Instruments

Jota 9828.RA.040 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-EJOT803204243525040) and listed in FDA GUDID since 2 Oct 2023 (UDI-DI EJOT803204243525040), 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-EJOT803204243525040 Basic UDI-DI EJOT803204243525040UDI-DIDate26 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberEJOT803204243525040 UDI-DI Date2 Oct 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-EJOT803204243525040 registered 26 Jun 2026 Active
  • FDA GUDID UDI-DI EJOT803204243525040 listed 2 Oct 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID EJOT803204243525040
  2. Registered EUDAMED B-EJOT803204243525040

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  • Withdrawn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
Dental polishing brush
Model / reference
Rotary Instruments EUDAMED
803204243525040 EUDAMED
9828.RA.040 GUDID
Primary DI / UDI-DI
EJOT803204243525040
Basic UDI-DI
B-EJOT803204243525040
FDA product code
EJQ
EMDN code
Q0199 Odontology devices - other
GMDN term
Dental polishing brush
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
803204243525040
GUDID
9828.RA.040
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 polishing brush

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)