Identity
- Trade Name
- XIOS FDA UDI
- Generic Name
- Instrument/equipment drape, single-use, non-sterile FDA UDI
- Device Name
- SIRONA S1 300 SENSOR SHEATHS UNIVERSAL SHEATHS SIZE 1 (300/PKG) FDA UDI
- Model / Reference
- B1070017 FDA UDI
- Description
- SIRONA S1 300 SENSOR SHEATHS UNIVERSAL SHEATHS SIZE 1 (300/PKG) FDA UDI
Identifiers
- Primary DI / UDI-DI
- D764B10700171 FDA UDI
- 510(k) Number
- K963664 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Instrument/equipment drape, single-use, non-sterile FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Instrument/equipment drape, single-use, non-sterile
Xios by Sirona Dental, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Instrument/equipment drape, single-use, non-sterile.
- Allrap Protective Barriers — METREX RESEARCH · Class I
- Premium Plus — Premium Plus International Limited · Class II
- Delasco Electrosurgical Handpiece Sheath — DERMATOLOGIC LAB AND SUPPLY, INC. · Class II
- SOLEIL — BENCO DENTAL SUPPLY CO. · Class II
- Pinnacle No-Slip Chair Sleeve — METREX RESEARCH · Class II
- Premium Plus — Premium Plus International Limited · Class II
- Pinnacle Sensor Cover — METREX RESEARCH · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
Cleared under the same submission
K963664 also covers:
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- SCHICK — SIRONA DENTAL, INC.
- SCHICK — SIRONA DENTAL, INC.
- SCHICK — SIRONA DENTAL, INC.
- SCHICK ELITE — SIRONA DENTAL, INC.
- SCHICK ELITE — SIRONA DENTAL, INC.
- SCHICK ELITE — SIRONA DENTAL, INC.
- SCHICK ELITE — SIRONA DENTAL, INC.
- SCHICK ELITE — SIRONA DENTAL, INC.
- SCHICK ELITE — SIRONA DENTAL, INC.
- XIOS — 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sirona Dental, Inc.
Sources (1)
- FDA UDI e8f0fff9-dc0b-487c-8c76-ef1038f8f8cf 35 fields · synced May 30, 2026