Identity
- Trade Name
- XIOS FDA UDI
- Generic Name
- Dental x-ray film holder, reusable FDA UDI
- Device Name
- SIRONA PERIAPICAL HLDR ASY KIT YELLOW FDA UDI
- Model / Reference
- 6176528 FDA UDI
- Description
- SIRONA PERIAPICAL HLDR ASY KIT YELLOW FDA UDI
Identifiers
- Primary DI / UDI-DI
- D76461765281 FDA UDI
- FDA Product Code
- EAP FDA UDI
- GMDN Term
- Dental x-ray film holder, reusable 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
Yes
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: Dental x-ray film holder, reusable
Xios by Sirona Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental x-ray film holder, reusable.
- DEXIS HORIZONTAL HAND-HELD UL-LR — Dental Imaging Technologies Corporation · Class I
- RINN® — Dentsply International · Class I
- TrollByte — Directa AB · Class I
- TrollByte — Directa AB · Class I
- Bar, Alignment, Universal, Short — Dental Imaging Technologies Corporation · Class I
- TrollByte — Directa AB · Class I
- TrollByte — Directa AB · Class I
- D-Series Size 1 Anterior AQUA Bite Block 3-Pack — CLIKTECH, LLC. · Class I
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 f7d8b3d8-734a-45cc-be40-561f5fc16573 34 fields · synced May 30, 2026