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OKTAGON Dental Implant BL NC 22009

by Hager & Meisinger Gesellschaft mit beschränkter Haftung

Ref 22009Model Oktagon Dental Implants

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

CE MDR

Valid until

6 Mar 2029

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier TÜV NORD CERT GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E0HM250IIB00AA2S Basic UDI-DI E0HM220091UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberE0HM220091 UDI-DI Date6 Jul 2021ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 44911220651 Active Supplemented

    Quality management system EU MDR

    Certifier
    TÜV NORD CERT GmbH 0044
    Issued
    12 Aug 2025
    Expires
    6 Mar 2029
    Reason
    Other

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
Oktagon EUDAMED
OKTAGON Dental Implant BL NC GUDID
Generic Name
Screw endosteal dental implant, two-piece
Model / Ref / Catalog
22009, Oktagon Dental Implants
Primary DI / UDI-DI
E0HM220091
Basic UDI-DI
++E0HM250IIB00AA2S
510(k) Number
FDA Product Code
DZE
EMDN Code
P01020101 Dental implants
GMDN Term
Screw endosteal dental implant, two-piece
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
872.3640
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Screw endosteal dental implant, two-piece

Cleared under the same submission (K143539)

Show all (12)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No