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Oktagon

EUDAMEDFDA 510(k)

Class I (EU MDR)

Ref 31178Model Accessories for prothetic parts510(k) K162073Ref 77452Model Prosthetic abutment systemsRef 55299

by Hager & Meisinger GmbH

Identity

Trade Name
Oktagon EUDAMED
Model / Reference
Accessories for prothetic parts EUDAMED
31178 EUDAMED
Prosthetic abutment systems EUDAMED
77452 EUDAMED
55299 EUDAMED

Identifiers

Primary DI / UDI-DI
E0HM311781 EUDAMED
E0HM774521 EUDAMED
E0HM3955299ZDRS001 EUDAMED
Basic UDI-DI
++E0HM311I04AAMQ EUDAMED
++E0HM305IIB00AA33 EUDAMED
++E0HM311I01AAM9 EUDAMED
510(k) Number
K162073 FDA 510(k)
FDA Product Code
DZE FDA 510(k)
EMDN Code
Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED

Classification

Device Class
Class I EUDAMED
Class IIb EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3640 FDA 510(k)
Regulation Number
872.3640 FDA 510(k)
Market of Registration
Germany EUDAMED
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMEDEUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Oktagon by Hager & Meisinger GmbH — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Hager & Meisinger GmbH
EUDAMED SRN
DE-MF-000004966

Sources (4)

  • EUDAMED a53830dd-edeb-4638-8c53-7b0135b3dad7 61 fields · synced Jul 22, 2026
  • FDA 510(k) K162073 24 fields · synced May 18, 2026
  • EUDAMED a4ceec24-c48b-4421-9831-153eb1fb8ea6 61 fields · synced Jul 13, 2026
  • EUDAMED 1c482753-4a94-4b8c-be55-c64805e8123b 61 fields · synced Jul 22, 2026