FDA UDI
In Commercial Distribution
🇺🇸 United States
OSUNG MND
DI: 08800075620958
·
Model: PW16
·
OSUNG MND Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- OSUNG MND
- Primary DI
- 08800075620958
- Version / Model
- PW16
- Company Name
- OSUNG MND Co., Ltd.
- Labeler DUNS
- 688207479
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-06
- Public Version
- 1
- Public Version Date
- 2024-03-14
- Public Version Status
- New
- Public Device Record Key
- 4c8b6863-6bb7-4915-bdd5-45d89d48900e
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EIL | Gauge, Depth, Instrument, Dental | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16370 | Dental wedge, reusable | A small, dental device intended to be introduced between two adjacent teeth for slight separation during a dental procedure. It is typically used during the placement of a filling material, or to stabilize and support other devices (e.g., a matrix band and/or rubber dam). It may include a removable shield intended to protect the healthy tooth/teeth from damage by the instruments. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800075620958 | GS1 |