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Lindemann Guide Drill OMD2228

by Ebi, Inc.

Ref OMD2228

Lindemann Guide Drill OMD2228 is a device classified as Class IIa in the EU and Class I in the US made by Ebi, Inc., registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI B-08809476188647) and listed in FDA GUDID since 4 Jul 2016 (UDI-DI 08809476188647), active as of 12 Nov 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809476188647 Basic UDI-DI 08809476188647UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809476188647 UDI-DI Date4 Jul 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08809476188647 registered 4 Nov 2026 Active
  • FDA GUDID UDI-DI 08809476188647 listed 4 Jul 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08809476188647
  2. Registered EUDAMED B-08809476188647

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  • Withdrawn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

Trade name
One more Drill EUDAMED
Lindemann Guide Drill GUDID
Generic name
Dental implant system
Model / reference
OMD2228
Primary DI / UDI-DI
08809476188647
Basic UDI-DI
B-08809476188647
FDA product code
EJL
EMDN code
Z12110102 Dental drills
GMDN term
Dental implant system
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3240
EU registration type
Legacy device (under a directive)
EU market of registration
Türkiye
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
ImplantableEUDAMED
No
GUDID
Yes

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: Dental implant system

Similar devices in this category

Other devices filed under DENTAL DRILLS.

Other devices from Ebi, Inc.

See all devices from Ebi, Inc. →

Properties

  • Sterilise before use
  • Implantable NoEUDAMEDYesGUDID
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)