Identity
- Trade Name
- SCHICK ELITE FDA UDI
- Generic Name
- Instrument/equipment drape, single-use, non-sterile FDA UDI
- Device Name
- SCHICK ELITE S1 300 SHEATHS KIT UNIVERSAL SHEATHS SIZE 1 (300/PKG) FDA UDI
- Model / Reference
- B1107011 FDA UDI
- Description
- SCHICK ELITE S1 300 SHEATHS KIT UNIVERSAL SHEATHS SIZE 1 (300/PKG) FDA UDI
Identifiers
- Primary DI / UDI-DI
- D764B11070110 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
Schick Elite by Sirona Dental, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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.
- XIOS — 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 |
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Manufacturer
- Manufacturer
- Sirona Dental, Inc.
Sources (1)
- FDA UDI 4e9a9ab1-2ad1-4260-be91-e6edda4ee605 35 fields · synced Jun 8, 2026