Identity
- Trade Name
- OSUNG MND FDA UDI
- Generic Name
- Dental elevator, sinus lift FDA UDI
- Device Name
- A hand-held, manual, dental surgical instrument specially designed to lift and displace sinus mucosa (Schneiderian membrane) from the maxillary sinus floor to allow for insertion of a bone graft during sinus lift surgery. It is typically a metal instrument with single- or double-ended blades. This is a reusable device. FDA UDI
- Model / Reference
- ISSC2 FDA UDI
- Description
- A hand-held, manual, dental surgical instrument specially designed to lift and displace sinus mucosa (Schneiderian membrane) from the maxillary sinus floor to allow for insertion of a bone graft during sinus lift surgery. It is typically a metal instrument with single- or double-ended blades. This is a reusable device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800075608376 FDA UDI
- FDA Product Code
- EMJ FDA UDI
- GMDN Term
- Dental elevator, sinus lift 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: Dental elevator, sinus lift
Osung Mnd by Osung Mnd Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental elevator, sinus lift.
- American Medicals — AMERICAN MEDICALS · Class I
- A. Titan Instruments — A.Titan Instruments · Class I
- ZOLL-DENTAL — Zoll-Dental · Class I
- devemed — devemed GmbH · Class I
- ELEVATOR — KLS-Martin L.P. · Class I
- Gracey Curette — OSSTEM IMPLANT Co., Ltd. · Class I
- Bone Condenser — OSSTEM IMPLANT Co., Ltd. · Class I
- A. Titan Instruments — A.Titan Instruments · 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 f5bd5c12-292d-4f3f-a6f4-8cf0091fbdaa 33 fields · synced May 31, 2026