Identity
- Trade Name
- FONA CDR DICOM FDA UDI
- Generic Name
- Diagnostic x-ray digital imaging system workstation application software FDA UDI
- Device Name
- FONA CDR DICOM 4.5 SOFTWARE - MULTI USER (ENGLISH) FDA UDI
- Model / Reference
- B1035106 FDA UDI
- Description
- FONA CDR DICOM 4.5 SOFTWARE - MULTI USER (ENGLISH) FDA UDI
Identifiers
- Primary DI / UDI-DI
- D764B10351060 FDA UDI
- 510(k) Number
- K933455 FDA UDI
- FDA Product Code
- EAP FDA UDI
- GMDN Term
- Diagnostic x-ray digital imaging system workstation application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1810 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Diagnostic x-ray digital imaging system workstation application software
Fona Cdr Dicom by Sirona Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K933455 also covers:
- CDR — SIRONA DENTAL, INC.
- CDR — SIRONA DENTAL, INC.
- CDR — SIRONA DENTAL, INC.
- CDR — SIRONA DENTAL, INC.
- CDR — SIRONA DENTAL, INC.
- CDR — SIRONA DENTAL, INC.
- CDR — SIRONA DENTAL, INC.
- FONA CDR — SIRONA DENTAL, INC.
- FONA CDR — SIRONA DENTAL, INC.
- XIOS — SIRONA DENTAL, INC.
- XIOS — SIRONA DENTAL, INC.
- XIOS XG WIFI — SIRONA DENTAL, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sirona Dental, Inc.
Sources (1)
- FDA UDI e820f0f7-724a-4874-8765-ff7c1434db3e 35 fields · synced Jun 8, 2026