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510(k) Data Aggregation
K Number
K991283Device Name
DYNA TORQ TORQUE WRENCH, TORQUE WRENCHManufacturer
Date Cleared
1999-08-18
(125 days)
Product Code
Regulation Number
872.3640Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Dyna Torq Torque Wrench is intended for use in fastening dental implant abutments during the placement of dental implants.
Device Description
Not Found
AI/ML Overview
This document is a 510(k) clearance letter from the FDA for a dental tool, the Dyna Torq® Torque Wrench. It does not contain information about studies, acceptance criteria, or device performance metrics as requested in the prompt. The letter merely states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on this document.
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