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P801.HP.018

by Jota AG

Ref 806104001523018Model Rotary Instruments

P801.HP.018 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-EJOT806104001523018) and listed in FDA GUDID since 15 Sep 2021 (UDI-DI EJOT806104001523018), 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-EJOT806104001523018 Basic UDI-DI EJOT806104001523018UDI-DIDate26 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberEJOT806104001523018 UDI-DI Date15 Sep 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-EJOT806104001523018 registered 26 Jun 2026 Active
  • FDA GUDID UDI-DI EJOT806104001523018 listed 15 Sep 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID EJOT806104001523018
  2. Registered EUDAMED B-EJOT806104001523018

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  • Withdrawn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
Diamond dental bur, reusable
Model / reference
Rotary Instruments EUDAMED
806104001523018 EUDAMED
P801.HP.018 GUDID
Primary DI / UDI-DI
EJOT806104001523018
Basic UDI-DI
B-EJOT806104001523018
FDA product code
HTT
EMDN code
L0916 Orthopaedic surgery burs and tips, reusable
GMDN term
Diamond 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
806104001523018
GUDID
P801.HP.018
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 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)