Identity
- Trade Name
- Anthos FDA UDI
- Generic Name
- Stationary intraoral dental x-ray system, digital FDA UDI
- Device Name
- ANTHOS RX DC - REF: ANEU174WS FDA UDI
- Model / Reference
- RX DC FDA UDI
- Description
- ANTHOS RX DC - REF: ANEU174WS FDA UDI
Identifiers
- Catalog Number
- 706Q0010 FDA UDI
- Primary DI / UDI-DI
- 08033837931577 FDA UDI
- 510(k) Number
- K163519 FDA UDI
- FDA Product Code
- EHD FDA UDI
- GMDN Term
- Stationary intraoral dental x-ray system, digital 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
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: Stationary intraoral dental x-ray system, digital
Anthos by Cefla Societa' Cooperativa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Stationary intraoral dental x-ray system, digital.
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- Owandy-RX DC — OWANDY RADIOLOGY · Class II
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Cleared under the same submission
K163519 also covers:
- Anthos — CEFLA SOCIETA' COOPERATIVA
- Anthos — CEFLA SOCIETA' COOPERATIVA
- Anthos — CEFLA SOCIETA' COOPERATIVA
- Castellini — CEFLA SOCIETA' COOPERATIVA
- Castellini — CEFLA SOCIETA' COOPERATIVA
- Castellini — CEFLA SOCIETA' COOPERATIVA
- Castellini — CEFLA SOCIETA' COOPERATIVA
- NewTom — CEFLA SOCIETA' COOPERATIVA
- NewTom — CEFLA SOCIETA' COOPERATIVA
- NewTom — CEFLA SOCIETA' COOPERATIVA
- NewTom — CEFLA SOCIETA' COOPERATIVA
- NewTom — CEFLA SOCIETA' COOPERATIVA
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
- Cefla Societa' Cooperativa
Sources (1)
- FDA UDI dd6b52fb-b56a-4ac4-990c-5257e7caeddb 37 fields · synced Jun 8, 2026