Identity
- Trade Name
- PXL FDA UDI
- Generic Name
- Intraoral camera FDA UDI
- Device Name
- PXL Intraoral Camera FDA UDI
- Model / Reference
- PXL-1000 FDA UDI
- Description
- PXL Intraoral Camera FDA UDI
Identifiers
- Catalog Number
- PXL-1000 FDA UDI
- Primary DI / UDI-DI
- 00813557020243 FDA UDI
- 510(k) Number
- K981663 FDA UDI
- FDA Product Code
- EIA FDA UDI
- GMDN Term
- Intraoral camera FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 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
Yes
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
No
FDA UDI
Category: Intraoral camera
Pxl by Digital Doc LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K981663 also covers:
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
- Digital Doc LLC
Sources (1)
- FDA UDI 67a50911-6948-49f0-981c-f4ebe5b7cfdb 35 fields · synced May 30, 2026