Identity
- Trade Name
- Glidewell™ Torque Wrench FDA UDI
- Generic Name
- Dental torque wrench FDA UDI
- Device Name
- The Glidewell Torque Wrench is made of lightweight titanium and stainless steel. The Torque Wrench & Driver product design, finish and quality make the tool well suited for placement and adjustment of implants, abutments and screws during surgery and other clinical procedures. The Torque Wrench & Driver is easy to prepare for cleaning, disinfection and sterilization. Exchangeable screwdrivers and the Driver make the tool compatible to various implant systems. The driver is available for a variety of connections. For specific product descriptions, please refer to individual product labels. FDA UDI
- Model / Reference
- 70-C35120 FDA UDI
- Description
- The Glidewell Torque Wrench is made of lightweight titanium and stainless steel. The Torque Wrench & Driver product design, finish and quality make the tool well suited for placement and adjustment of implants, abutments and screws during surgery and other clinical procedures. The Torque Wrench & Driver is easy to prepare for cleaning, disinfection and sterilization. Exchangeable screwdrivers and the Driver make the tool compatible to various implant systems. The driver is available for a variety of connections. For specific product descriptions, please refer to individual product labels. FDA UDI
Identifiers
- Catalog Number
- 70-C35120 FDA UDI
- Primary DI / UDI-DI
- 05712821013729 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental torque wrench FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 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
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental torque wrench
Glidewell™ Torque Wrench by Elos Medtech Pinol A/S — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Elos Medtech Pinol A/S
Sources (1)
- FDA UDI 1f9c261a-5641-4aec-8d84-ef154c980cc5 34 fields · synced Jun 1, 2026