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OKTAGON Dental Implant TL WP 93727

by Hager & Meisinger Gesellschaft mit beschränkter Haftung EUDAMEDGUDID

Active European Union

Ref 93727Model Oktagon Dental Implants

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E0HM250IIB02AA34 Basic UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberE0HM937271 UDI-DIDate12 Jul 2021ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 44911220651 Active Supplemented

    Quality management system EU MDR

    Notified body
    0044
    Issued
    12 Aug 2025
    Expires
    6 Mar 2029
    Reason
    Other

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Oktagon EUDAMED
OKTAGON Dental Implant TL WP GUDID
Generic Name
Screw endosteal dental implant, two-piece
Model / Ref / Catalog
93727, Oktagon Dental Implants
Primary DI / UDI-DI
E0HM937271
Basic UDI-DI
++E0HM250IIB02AA34
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
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 (K122807)

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