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NobelZygoma™ Lateral Burr Fine

by Nobel Biocare AB

Ref 301694

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number73327470000001206M Basic UDI-DI 07332747200447UDI-DIDate4 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07332747200447 UDI-DI Date13 Oct 2025ListedStatusListed 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  • Withdrawn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
NobelZygoma™ Lateral Burr Fine EUDAMED
NobelZygoma™ TiUltra™ GUDID
Generic Name
Fixture/appliance dental drill bit, single-use
Device Name
Drills for osteotomy
Model / Ref / Catalog
301694
Primary DI / UDI-DI
07332747200447
Basic UDI-DI
73327470000001206M
FDA Product Code
EJL
EMDN Code
Q010501 Dental burs and abrasive disks, single-use
GMDN Term
Fixture/appliance dental drill bit, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.3240
EU market of registration
Sweden
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
SE-MF-000000009

Related devices

Category: Carbide dental bur, single-use

Other devices from Nobel Biocare AB

See all devices from Nobel Biocare AB →

Properties

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

Other properties (17)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No