Identity
- Trade Name
- PROX FDA UDI
- Generic Name
- Hand-held intraoral dental x-ray system, digital FDA UDI
- Device Name
- The PROX is a hand-held diagnostic dental x-ray system. It is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source producing diagnostic X-ray images using with intra-oral image receptors. Its use is intended for adults and pediatric subjects both. This device includes a high frequency inverter that changes direct current to alternating current, X-ray tube, electrical protective devices, and other elements. The system helps to get sharp and clear x-ray images, and its low radiation dosage keeps patients and dentists safe from leakage radiation. FDA UDI
- Model / Reference
- PROX EUDAMEDDMC-04 EUDAMED1 FDA UDI
- Description
- The PROX is a hand-held diagnostic dental x-ray system. It is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source producing diagnostic X-ray images using with intra-oral image receptors. Its use is intended for adults and pediatric subjects both. This device includes a high frequency inverter that changes direct current to alternating current, X-ray tube, electrical protective devices, and other elements. The system helps to get sharp and clear x-ray images, and its low radiation dosage keeps patients and dentists safe from leakage radiation. FDA UDI
Identifiers
- Catalog Number
- DPC-04 FDA UDI
- Primary DI / UDI-DI
- 08800021800007 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800021800007 EUDAMED
- 510(k) Number
- K082167 FDA UDI
- FDA Product Code
- EHD FDA UDI
- EMDN Code
- Z1103040102 EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY EUDAMED
- GMDN Term
- Hand-held intraoral dental x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.1800 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental digital imaging sensor, intraoral
Dmc-04 by DigiMed Co., Ltd. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800021800007 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- DIGIMED Co., Ltd.
- EUDAMED SRN
- KR-MF-000016608
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (2)
- EUDAMED 10240dee-2ab3-446d-988d-e9885166eb67 61 fields · synced Jul 28, 2026
- FDA UDI 10d66177-1945-4841-a4c5-049f85c06df6 37 fields · synced May 30, 2026