Identity
- Trade Name
- DEXcam3™ intraoral cameras FDA UDI
- Generic Name
- Multi-purpose digital medical camera FDA UDI
- Device Name
- Digital intraoral camera FDA UDI
- Model / Reference
- 1.007.1333 FDA UDI
- Description
- Digital intraoral camera FDA UDI
Identifiers
- Catalog Number
- PLU790 FDA UDI
- Primary DI / UDI-DI
- EKAV100713330 FDA UDI
- 510(k) Number
- K040691 FDA UDI
- FDA Product Code
- EIA FDA UDI
- GMDN Term
- Multi-purpose digital medical 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Multi-purpose digital medical camera
DEXcam3™ intraoral cameras by Dexis Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K040691 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
- Dexis Llc
Sources (1)
- FDA UDI 64a3e517-81a1-4d25-b560-6dd2eba5c9d4 37 fields · synced May 30, 2026