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Oktagon

by Hager & Meisinger GmbH EUDAMEDGUDID

Active European Union and United States

Ref 31185, 31055, 77201, 31182, 31179, 77200, 31186, 77301, 31177, 77500, 93745, 55478, 77101, 31180, 82891, 55394, 31181, 77703, 84957, 31183, 55283, 63980Model Accessories for prothetic parts, Accessories implantology and oral surgery, Bur blocks and trays

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E0HM311I04AAMQ Basic UDI-DIDate19 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID NumberE0HM311851 UDI-DIDate15 Sep 2021ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Oktagon EUDAMED
Oktagon® GUDID
OKTAGON TL RP Abutment angled 15° A H= 5.7 mm cementable GUDID
OKTAGON TL RP ALLIGATOR Abutment angled, 15°, H 3.0 mm GUDID
OKTAGON BL RC ALLIGATOR Abutment angled 15° GH 4.0 mm GUDID
OKTAGON TL WP Healing abutment GH 2.0mm GUDID
OKTAGON BL NC ALLIGATOR Abutment angled 15° GH 3 mm GUDID
OKTAGON BL RC Healing abutment, conical Ø 6.5 mm GH 2.0 mm GUDID
OKTAGON BL RC ALLIGATOR Abutment GH 3.0 mm GUDID
OKTAGON BL NC Healing abutment, conical Ø4.8 mm GH 3.5 mm GUDID
OKTAGON TL RP Solid abutment yellow, 6°, H 4.0 mm GUDID
OKTAGON TL RP ALLIGATOR Abutment angled, 15°, H 1.5 mm GUDID
OKTAGON TL WP Cover screw GH 0.0 mm GUDID
OKTAGON TL RP ALLIGATOR Abutment GH 1.0 mm GUDID
OKTAGON TL RP Abutment ball attachment GH 0.0 mm GUDID
OKTAGON BL RC ALLIGATOR Abutment GH 1.0 mm GUDID
OKTAGON BL NC Healing abutment, conical Ø3.6 mm GH 2.0 mm GUDID
OKTAGON BL RC ALLIGATOR Abutment GH 2.0 mm GUDID
OKTAGON BL RC Abutment, 0°, Ø 5.0 mm L 6.0 mm, GH 1.0 mm, cementable basic screw GUDID
OKTAGON TL RP Cover screw large GH 1.5 mm GUDID
OKTAGON BL NC ALLIGATOR Abutment GH 4.0 mm GUDID
OKTAGON BL NC Abutment 0° Ø 3.5 mm, L 5.5 mm GH 2.0 mm, cementable basic screw 2 GUDID
OKTAGON TL RP Abutment angled 20° A H= 5.7 mm cementable GUDID
OKTAGON BL NC Cover screw GH 0.0 mm GUDID
OKTAGON BL NC Healing abutment, conical Ø4.8 mm GH 2.0 mm GUDID
OKTAGON BL RC ALLIGATOR Abutment GH 4.0 mm GUDID
OKTAGON BL RC Cover screw GH 0.5 mm GUDID
OKTAGON TL WP Abutment angled, 15° A H 5.5 mm, cementable GUDID
Generic Name
Manual non-rotary dental instrument handle
Dental implant suprastructure, permanent, preformed
Screw endosteal dental implant, two-piece
Model / Ref / Catalog
Accessories for prothetic parts, 31185, Accessories implantology and oral surgery, 31055, 77201, 31182, 31179, 77200, 31186, 77301, 31177, 77500, 93745, 55478, 77101, 31180, Bur blocks and trays, 82891, 55394, 31181, 77703, 84957, 31183, 55283, 63980, 93722, 82648, 98008, 22130, 93731, 22041, 22093, 22126, 22021, 81038, 98007, 93730, 98001, 38087, 22124, 22017, 22125, 22106, 31155, 22038, 22028, 38119, 22013, 22020, 22127, 22099, 87434, 93739
Primary DI / UDI-DI
E0HM311851, E0HM310551, E0HM772011, E0HM311821, E0HM311791, E0HM772001, E0HM311861, E0HM773011, E0HM311771, E0HM775001, E0HM937451, E0HM3955478ZDRS001, E0HM771011, E0HM311801, E0HM828911, E0HM3955394ZDRS001, E0HM311811, E0HM777031, E0HM3984957ZDRS001, E0HM311831, E0HM3955283ZDRS001, E0HM639801, E0HM937221, E0HM826481, E0HM980081, E0HM221301, E0HM937311, E0HM220411, E0HM220931, E0HM221261, E0HM220211, E0HM810381, E0HM980071, E0HM937301, E0HM980011, E0HM380871, E0HM221241, E0HM220171, E0HM221251, E0HM221061, E0HM311551, E0HM220381, E0HM220281, E0HM381191, E0HM220131, E0HM220201, E0HM221271, E0HM220991, E0HM874341, E0HM937391
Basic UDI-DI
++E0HM311I04AAMQ, ++E0HM351I05AAPZ, ++E0HM311I04ABMS, ++E0HM311I02ACMJ, ++E0HM311I01AAM9, ++E0HM400I00AALR
510(k) Number
FDA Product Code
NDP, NHA, DZE
EMDN Code
Q010280, Q0199, V0480
GMDN Term
Manual non-rotary dental instrument handle
Dental implant suprastructure, permanent, preformed
Screw endosteal dental implant, two-piece
Device Class
Class I EUDAMEDGUDID
Class II GUDID
Regulation Number
872.3980, 872.3630, 872.3640
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class I
Class II
ImplantableEUDAMED
No
GUDID
No
Yes

Manufacturer details

EUDAMED SRN
DE-MF-000004966

Other devices from Hager & Meisinger GmbH

See all devices from Hager & Meisinger GmbH →

Properties

  • Single Use YesGUDIDNoGUDID
  • Implantable NoEUDAMEDGUDIDYesGUDID
  • Prescription Use
  • Premarket Exempt YesGUDIDNoGUDID
  • Lot / Batch Number

Other properties (19)

  • Sterile: 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
  • Expiration Date: No
  • Manufacturing Date: No