Identity
- Trade Name
- Eighteeth FDA UDI
- Generic Name
- Dental digital imaging sensor, intraoral FDA UDI
- Device Name
- The NanoPix series sensors (NanoPix1, NanoPix1.5, NanoPix2) are USB-driven digital intraoral sensors based on a CMOS (Complementary Metal Oxide Semiconductor) technology that has been specifically designed for dental applications. The NanoPix series intraoral sensors provide digital diagnostic image capture to replace radiographic film/screen system in general dental diagnostic procedures. The captured digital image is transferred to personal computer via USB port. FDA UDI
- Model / Reference
- NanoPix1.5 FDA UDI
- Description
- The NanoPix series sensors (NanoPix1, NanoPix1.5, NanoPix2) are USB-driven digital intraoral sensors based on a CMOS (Complementary Metal Oxide Semiconductor) technology that has been specifically designed for dental applications. The NanoPix series intraoral sensors provide digital diagnostic image capture to replace radiographic film/screen system in general dental diagnostic procedures. The captured digital image is transferred to personal computer via USB port. FDA UDI
Identifiers
- Catalog Number
- 6980098 FDA UDI
- Primary DI / UDI-DI
- 06941877815196 FDA UDI
- 510(k) Number
- K220422 FDA UDI
- FDA Product Code
- MUH FDA UDI
- GMDN Term
- Dental digital imaging sensor, intraoral FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1800 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental digital imaging sensor, intraoral
Eighteeth by Changzhou Sifary Medical Technology 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
- Changzhou Sifary Medical Technology Co., Ltd.
Sources (1)
- FDA UDI 73d3bc6e-8e4c-403f-b1d1-a39b198c79f5 35 fields · synced May 30, 2026