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Jota C31.HP.010

by Jota AG

Ref 500104107007010Model Rotary Instruments

Jota C31.HP.010 is a carbide dental bur (EU MDD Class IIa; FDA Class I; FDA product code DZA, Drill, Dental, Intraoral) made by Jota AG, registered in EUDAMED on 26 Jun 2026 (Basic UDI-DI B-EJOT500104107007010) and listed in FDA GUDID since 7 Feb 2024 (UDI-DI EJOT500104107007010), 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-EJOT500104107007010 Basic UDI-DI EJOT500104107007010UDI-DIDate26 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberEJOT500104107007010 UDI-DI Date7 Feb 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-EJOT500104107007010 registered 26 Jun 2026 Active
  • FDA GUDID UDI-DI EJOT500104107007010 listed 7 Feb 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID EJOT500104107007010
  2. Registered EUDAMED B-EJOT500104107007010

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  • Withdrawn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
Carbide dental bur, reusable
Model / reference
Rotary Instruments EUDAMED
500104107007010 EUDAMED
C31.HP.010 GUDID
Primary DI / UDI-DI
EJOT500104107007010
Basic UDI-DI
B-EJOT500104107007010
FDA product code
DZA
EMDN code
Q010399 Surgical dental devices - other
GMDN term
Carbide dental bur, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.4130
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
500104107007010
GUDID
C31.HP.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: Carbide dental bur, reusable

Similar devices in this category

Other devices filed under SURGICAL DENTAL DEVICES - OTHER.

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Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)