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Torque Wrench

Elos Medtech Pinol A/S · Model C15224 · UDI-DI 05712821007643

NDP Prescription
4
510(k) clearances
5,022
Adverse events
57
Recalls
530
Facilities

Description

The Elos Torque Wrench (main body, head and Elos Driver) is made of lightweight titanium and stainless steel. The Elos 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 Elos Torque Wrench & Driver is easy to prepare for cleaning, disinfection and sterilization. Exchangeable screwdrivers and the Elos 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.

Recalls

DateFirmReason
2026-01-06Straumann USA LLCThe mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
2025-07-24Dentsply IH, Inc.The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage appr
2025-07-24Dentsply IH, Inc.The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage appr
2025-04-14Prismatik Dentalcraft, Inc.Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
2025-03-08Straumann USA LLCThe devices are missing the laser marked depth markings.
2024-06-25Preat CorpDue to a manufacturing issue, the product has a out of specification rotation of the digital analog used to visually inspect dental abutments and restorations.
2024-01-24Thommen Medical AGThe depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
2023-12-27TruAbutment Inc.Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately
2021-07-26Paltop Advanced Dental Solutions LtdSome devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size eng
2021-07-26Paltop Advanced Dental Solutions LtdSome devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size eng

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.