Identity
- Trade Name
- RINN® FDA UDI
- Generic Name
- Dental x-ray film holder, reusable FDA UDI
- Device Name
- XCP-DS Fit® Endodontic Kit. Contains: 1 Endo Arm and Ring, 2 XCP-DS FIT® Endo Biteblocks. FDA UDI
- Model / Reference
- 559908 FDA UDI
- Description
- XCP-DS Fit® Endodontic Kit. Contains: 1 Endo Arm and Ring, 2 XCP-DS FIT® Endo Biteblocks. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D0035599081 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
- 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
No
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
Category: Medical equipment/instrument drape, single-useDental x-ray film holder, reusable
Rinn® by Dentsply International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 8120fb14-6f10-49af-a47a-e46467a744c8 35 fields · synced May 30, 2026