Identity
- Trade Name
- OSUNG MND FDA UDI
- Generic Name
- Manual non-rotary dental instrument handle FDA UDI
- Device Name
- A hand-held, manual device designed to hold and facilitate manipulation of a non-powered, non-rotary dental instrument (e.g., endodontic file/rasp, implant extractor). It is designed to accept the patient-contact endpiece (not included) for ease of handling. This is a reusable device. FDA UDI
- Model / Reference
- 2MHC3 FDA UDI
- Description
- A hand-held, manual device designed to hold and facilitate manipulation of a non-powered, non-rotary dental instrument (e.g., endodontic file/rasp, implant extractor). It is designed to accept the patient-contact endpiece (not included) for ease of handling. This is a reusable device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800075626165 FDA UDI
- FDA Product Code
- EJB FDA UDI
- GMDN Term
- Manual non-rotary dental instrument handle FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Manual non-rotary dental instrument handle
Osung Mnd by Osung Mnd Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual non-rotary dental instrument handle.
- OKTAGON® — Hager & Meisinger Gesellschaft mit beschränkter Haftung · Class I
- OKTAGON® — Hager & Meisinger Gesellschaft mit beschränkter Haftung · Class I
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC. · Class I
- Implantium, Superline — Dentium Co., Ltd. · Class I
- Medentika — Medentika GmbH · Class I
- DS Implants — Dentsply Implants Manufacturing GmbH · Class I
- Implantium, Superline — Dentium Co., Ltd. · Class I
- OKTAGON® — Hager & Meisinger Gesellschaft mit beschränkter Haftung · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Osung Mnd Co., Ltd.
Sources (1)
- FDA UDI df255a79-d0d2-4699-a7c9-f0fd104409de 33 fields · synced Jun 6, 2026