Identity
- Trade Name
- Straumann Extraoral Implant System FDA UDI
- Generic Name
- Dental torque wrench FDA UDI
- Device Name
- EO implant iserting device, Length 10.0 mm, Stainless steel, PEEK FDA UDI
- Model / Reference
- EO FDA UDI
- Description
- EO implant iserting device, Length 10.0 mm, Stainless steel, PEEK FDA UDI
Identifiers
- Catalog Number
- 046.177 FDA UDI
- Primary DI / UDI-DI
- 07630031721433 FDA UDI
- FDA Product Code
- KCZ FDA UDI
- GMDN Term
- Dental torque wrench FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.3800 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 10 Millimeter FDA UDI
Straumann Extraoral Implant System by Institut Straumann SA — Class I — 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Institut Straumann SA
Sources (1)
- FDA UDI 92e2700d-2774-41c0-af59-0fd2980b2c99 37 fields · synced May 31, 2026