Identity
- Trade Name
- OSUNG MND FDA UDI
- Generic Name
- Dental spatula, reusable FDA UDI
- Device Name
- A hand-held manual dental device used to manipulate filling materials in the plastic state. It is typically made of stainless steel with a small, flat, blunt blade (no sharp edges) at one end, or it may be double-ended. This is a reusable device. FDA UDI
- Model / Reference
- SPPS FDA UDI
- Description
- A hand-held manual dental device used to manipulate filling materials in the plastic state. It is typically made of stainless steel with a small, flat, blunt blade (no sharp edges) at one end, or it may be double-ended. This is a reusable device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800075626363 FDA UDI
- FDA Product Code
- GAF FDA UDI
- GMDN Term
- Dental spatula, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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 spatula, reusable
Osung Mnd by Osung Mnd Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Power Dental USA — Power Dental USA, Inc. · Class I
- Power Dental USA — Power Dental USA, 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 ee82be3a-2557-4b05-a82a-6a2360a06328 33 fields · synced Jun 8, 2026