Oktagon®

FDA UDI

Class I (US FDA UDI)

by Hager & Meisinger Gesellschaft mit beschränkter Haftung

Identity

Trade Name: OKTAGON® FDA UDI
Generic Name: Manual non-rotary dental instrument handle FDA UDI
Device Name: Rotary instrument für surgical application FDA UDI
Model / Reference: 22137 FDA UDI
Description: Rotary instrument für surgical application FDA UDI

Identifiers

Catalog Number: 22137 FDA UDI
Primary DI / UDI-DI: E0HM221371 FDA UDI
FDA Product Code: GFF FDA UDI
GMDN Term: Manual non-rotary dental instrument handle FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4820 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Manual non-rotary dental instrument handle

Oktagon® by Hager & Meisinger Gesellschaft mit beschränkter Haftung — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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OSUNG MND — Osung Mnd Co., Ltd. · Class I
Implantium, Superline — Dentium Co., Ltd. · Class I
Bioclear Instrument — Bioclear Matrix Systems, LLC · Class I
Bioclear Instrument — Bioclear Matrix Systems, LLC · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Hager & Meisinger Gesellschaft mit beschränkter Haftung

Sources (1)

FDA UDI 33564614-1b35-499e-a1a3-e08da61fbe41 35 fields · synced Jun 7, 2026