Identity
- Trade Name
- FONA CDR FDA UDI
- Generic Name
- Dental digital imaging sensor, intraoral FDA UDI
- Device Name
- FONA CDR SENSOR SIZE 1 FDA UDI
- Model / Reference
- B1112100 FDA UDI
- Description
- FONA CDR SENSOR SIZE 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D764B11121000 FDA UDI
- 510(k) Number
- K933455 FDA UDI
- FDA Product Code
- EAP FDA UDI
- GMDN Term
- Dental digital imaging sensor, intraoral 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental digital imaging sensor, intraoral
Fona Cdr by Sirona Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental digital imaging sensor, intraoral.
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- Schick — Dentsply International · Class II
- BMS DENTAL — NEW LIFE RADIOLOGY Srl · Class IIb
- Midmark OptiMax Digital Sensor System — Midmark Corporation · Class II
- Beyes — Beyes Dental Canada Inc · Class II
- Midmark OptiMax Digital Sensor System — Midmark Corporation · Class II
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 DICOM — 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 |
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Manufacturer
- Manufacturer
- Sirona Dental, Inc.
Sources (1)
- FDA UDI eeea1752-821b-4988-82a0-025bcce72a57 35 fields · synced May 30, 2026