OKTAGON BL NC Healing abutment Ø 5.0 mm 22033

by Hager & Meisinger Gesellschaft mit beschränkter Haftung 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 22 Oct 2026

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	NumberE0HM220331 UDI-DI	Date6 Jul 2021Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: OKTAGON BL NC Healing abutment Ø 5.0 mm
Generic Name: Screw endosteal dental implant, two-piece
Model / Ref / Catalog: 22033

Primary DI / UDI-DI: E0HM220331
510(k) Number: K143539
FDA Product Code: DZE
GMDN Term: Screw endosteal dental implant, two-piece

Device Class: Class II
Regulation Number: 872.3640
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

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Class I

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Properties

Single Use
Implantable
Prescription Use
Lot / Batch Number

Other properties (10)

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