Identity
- Trade Name
- OSUNG MND FDA UDI
- Generic Name
- Dental wedge, reusable FDA UDI
- Device Name
- A dental device that is positioned wedge-like at the interdental and cervical area of the teeth during routine intraoral dental procedures. It is used to slightly separate the teeth during the placement of a filling material, or to stabilize and support other devices, e.g., a matrix band or a rubber dam. This is a reusable device. FDA UDI
- Model / Reference
- PW16 FDA UDI
- Description
- A dental device that is positioned wedge-like at the interdental and cervical area of the teeth during routine intraoral dental procedures. It is used to slightly separate the teeth during the placement of a filling material, or to stabilize and support other devices, e.g., a matrix band or a rubber dam. This is a reusable device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800075620958 FDA UDI
- FDA Product Code
- EIL FDA UDI
- GMDN Term
- Dental wedge, reusable 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 wedge, reusable
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 wedge, reusable.
- Plasdent — PLASDENT CORP. · Class I
- Plasdent — PLASDENT CORP. · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Dental Matrix System Wedges — DENOVO DENTAL INC · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Plasdent — PLASDENT CORP. · Class I
- Wagotrix — GoldenDent · Class I
- Wagotrix — GoldenDent · 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 4c8b6863-6bb7-4915-bdd5-45d89d48900e 33 fields · synced May 31, 2026