Identity
- Trade Name
- Osstem Implant Co.,Ltd. FDA UDI
- Generic Name
- Intraoral camera FDA UDI
- Device Name
- The intraoral camera with a B applied Part is intended to provide a dentist with the ability to view the oral cavity prior to and subsequent to dental procedures. It can be connected to a USB hub that is connected to be directly connected to a Laptop or Desktop computer USB ports. FDA UDI
- Model / Reference
- SNAP Wired FDA UDI
- Description
- The intraoral camera with a B applied Part is intended to provide a dentist with the ability to view the oral cavity prior to and subsequent to dental procedures. It can be connected to a USB hub that is connected to be directly connected to a Laptop or Desktop computer USB ports. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800000995656 FDA UDI
- FDA Product Code
- QJK FDA UDI
- GMDN Term
- Intraoral camera FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3661 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Intraoral camera
Osstem Implant Co., Ltd. by OSSTEM IMPLANT Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- OSSTEM IMPLANT Co., Ltd.
Sources (1)
- FDA UDI 62ffa037-d411-443f-9340-fcc373f6eb86 33 fields · synced May 30, 2026