Identity
- Trade Name
- OSUNG MND FDA UDI
- Generic Name
- Orthodontic pliers FDA UDI
- Device Name
- A hand-held manual dental instrument designed to hold small objects or to bend or to cut metal strips or wire used in orthodontic procedures. It is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot point to terminate with jaws available in various shapes depending on intended use. This is a reusable device. FDA UDI
- Model / Reference
- OPDE02 FDA UDI
- Description
- A hand-held manual dental instrument designed to hold small objects or to bend or to cut metal strips or wire used in orthodontic procedures. It is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot point to terminate with jaws available in various shapes depending on intended use. This is a reusable device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800075622099 FDA UDI
- FDA Product Code
- JEX FDA UDI
- GMDN Term
- Orthodontic pliers 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
MR Conditional FDA UDI
Category: Orthodontic pliers
Osung Mnd by Osung Mnd Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic pliers.
- MIRABAY — MIRABAY ORTHODONTICS CORPORATION · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Falcon — ORTHO TECHNOLOGY, INC. · Class I
- J&J Instruments — J&J Instruments, LLC · Class I
- FOR BENDING 45° WIRES — ZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDA · Class I
- Orthopli — ORTHOPLI CORP. · Class I
- Power Dental USA — Power Dental USA, Inc. · Class I
- Triumph® — Ortho Organizers, Inc. · 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
- Osung Mnd Co., Ltd.
Sources (1)
- FDA UDI 9dec3297-3bef-4d0b-9863-07ee28a1ebdd 33 fields · synced Jun 8, 2026