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MDT Diamond Coated Dental Burs

by MDT Micro Diamond Technologies Ltd. 1,000+ variants

Ref 154419-35-61

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

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

Overview

A cutting-edge sterilization system for dental procedures, the MDT Diamond Coated Dental Burs offers unparalleled precision and safety. This innovative device features a diamond-coated surface, allowing for efficient and effective removal of tissue during surgical treatments. By leveraging advanced microdiamond technology, it provides optimal sterilization results, ensuring patient comfort and minimizing the risk of infection.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7291046DiamondSterileFM Basic UDI-DI 67291046157185UDI-DIDate17 Nov 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number67291046157185 UDI-DI Date8 May 2024ListedStatusListed 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

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
MDT Diamond Coated Dental Burs EUDAMED
MDT Diamond Coated Dental Burs -Sterile GUDID
Generic Name
Diamond dental bur, single-use
Device Name
Sterile Diamond Coated Dental Burs
Model / Ref / Catalog
154419-35-61, 544-019SC
Primary DI / UDI-DI
67291046157185
Basic UDI-DI
7291046DiamondSterileFM
FDA Product Code
DZP
EMDN Code
Q010501 Dental burs and abrasive disks, single-use
GMDN Term
Diamond dental bur, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.4535
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
IL-MF-000008464
Authorised representative
Obelis s.a. BE-AR-000000106

Related devices

Category: Carbide dental bur, single-use

Other devices from MDT Micro Diamond Technologies Ltd.

See all devices from MDT Micro Diamond Technologies Ltd. →

Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No