Skip to content

84RF.HP.080

by Jota AG

Ref 330104103172080Model Rotary Instruments

84RF.HP.080 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-EJOT330104103172080) and listed in FDA GUDID since 15 Sep 2021 (UDI-DI EJOT330104103172080), 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-EJOT330104103172080 Basic UDI-DI EJOT330104103172080UDI-DIDate26 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberEJOT330104103172080 UDI-DI Date15 Sep 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-EJOT330104103172080 registered 26 Jun 2026 Active
  • FDA GUDID UDI-DI EJOT330104103172080 listed 15 Sep 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID EJOT330104103172080
  2. Registered EUDAMED B-EJOT330104103172080

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  • Withdrawn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
Steel dental bur, reusable
Model / reference
Rotary Instruments EUDAMED
330104103172080 EUDAMED
84RF.HP.080 GUDID
Primary DI / UDI-DI
EJOT330104103172080
Basic UDI-DI
B-EJOT330104103172080
FDA product code
HTT
EMDN code
L0916 Orthopaedic surgery burs and tips, reusable
GMDN term
Steel dental bur, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
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
330104103172080
GUDID
84RF.HP.080
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: Steel dental bur, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE.

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)