Identity
- Trade Name
- RINN® FDA UDI
- Generic Name
- Dental x-ray film holder, reusable FDA UDI
- Device Name
- XCP-DS FIT® Universal Sensor Holder. Trial Pack Contains: 1 XCP-ORA® Arm and Ring, 2 Biteblocks, 2 Bitewings (1 Vertical, 1 Horizontal), 50 Universal Sensor Covers. FDA UDI
- Model / Reference
- 559911 FDA UDI
- Description
- XCP-DS FIT® Universal Sensor Holder. Trial Pack Contains: 1 XCP-ORA® Arm and Ring, 2 Biteblocks, 2 Bitewings (1 Vertical, 1 Horizontal), 50 Universal Sensor Covers. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D0035599111 FDA UDI
- FDA Product Code
- PEM FDA UDIEGZ FDA UDI
- GMDN Term
- Dental x-ray film holder, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI872.1905 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Rinn® by Dentsply International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Dentsply International
Sources (1)
- FDA UDI c5fb2926-e29b-48f2-a1db-f9b0f445b977 36 fields · synced May 31, 2026