Oktagon® 57042

by Hager & Meisinger Gesellschaft mit beschränkter Haftung

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberE0HM570421 UDI-DI	Date15 Sep 2021Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Oktagon®
Generic Name: Dental implant suprastructure, permanent, preformed
Model / Ref / Catalog: 57042

Primary DI / UDI-DI: E0HM570421
FDA Product Code: NDP
GMDN Term: Dental implant suprastructure, permanent, preformed

Device Class: Class I
Regulation Number: 872.3980
GUDID distribution status: In Commercial Distribution

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Class I
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Class I
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Class I
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Class I

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Properties

Single Use
Implantable
Prescription Use
Premarket Exempt
Lot / Batch Number

Other properties (9)

Sterile: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No