C379.FG.023

Ref 500314277072023Model Rotary Instruments

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-EJOT500314277072023 Basic UDI-DI EJOT500314277072023UDI-DI	Date26 Jun 2026Registered	StatusActive
United States	GUDID listing GUDID	NumberEJOT500314277072023 UDI-DI	Date15 Sep 2021Listed	StatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDD Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name: Carbide dental bur, reusable
Model / reference: Rotary Instruments EUDAMED
500314277072023 EUDAMED
C379.FG.023 GUDID

Primary DI / UDI-DI: EJOT500314277072023
Basic UDI-DI: B-EJOT500314277072023
FDA product code: EKD
EMDN code: Q0199 Odontology devices - other
GMDN term: Carbide dental bur, reusable

Device class: Class IIa EUDAMED
Class I GUDID
Regulation number: 872.4565
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

Field	EUDAMED	GUDID
Model / reference	EUDAMED Rotary Instruments 500314277072023	GUDID C379.FG.023
Device class	EUDAMED Class IIa	GUDID Class I

Other devices from Jota AG

Jota 1410

Class I
Jota 1489

Class I
Jota 1536

Class I
Jota 1541

Class I
Jota 1542

Class I
Jota 1551

Class I

See all devices from Jota AG →

Properties

Sterilise before use
Reusable
Prescription use
Premarket exempt
Lot / batch number

Other properties (20)

Supplied sterile: No
Single use: No
Implantable: No
Contains latex: No
Reprocessed single-use device: No
Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
Incorporates a substance derived from human blood or plasma: No
Contains human tissues or cells: No
Contains animal tissues or cells: No
Contains endocrine-disrupting substances: No
Administering medicine: No
Measuring function: No
Incorporates a medicinal substance: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Serial number: No
Expiration date: No
Manufacturing date: No