Identity
- Trade Name
- OSUNG MND FDA UDI
- Generic Name
- Periodontal knife FDA UDI
- Device Name
- A hand-held dental instrument used to excise the gums and other oral soft tissue during a periodontal intervention (e.g., a gingivectomy involving the excising of the soft tissue wall of a pocket). It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade of various shapes and sizes along the working end. It can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. This is a reusable device. FDA UDI
- Model / Reference
- PRTU FDA UDI
- Description
- A hand-held dental instrument used to excise the gums and other oral soft tissue during a periodontal intervention (e.g., a gingivectomy involving the excising of the soft tissue wall of a pocket). It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade of various shapes and sizes along the working end. It can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. This is a reusable device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800075605429 FDA UDI
- FDA Product Code
- EMO FDA UDI
- GMDN Term
- Periodontal knife 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: Periodontal knife
Osung Mnd by Osung Mnd Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Periodontal knife.
- ZOLL-DENTAL — Zoll-Dental · Class I
- CHAO PINHOLE KIT DLC — W.H. Holden, Inc. · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Sklar — Sklar Corporation · Class I
- BMT Medizintechnik GmbH — BMT Medizintechnik GmbH · Class I
- ZOLL DENTAL — Zoll-Dental · Class I
- 4-B Medium — W.H. Holden, Inc. · Class I
- BMT Medizintechnik GmbH — BMT Medizintechnik GmbH · 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 1e220403-3c1a-4cf2-8616-01d0031a0fd3 33 fields · synced May 30, 2026