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The Indications for Use of this device is to provide a dental professional a lowspeed handpiece which may be used, in conjunction with various dental burs as identified by the dental professional, in the performance of various dental procedures including, but not limited to, Prophy, Post and Pin Drilling, Pin Setting, Root Canal Enlargement and Sealing, and Caries Removal. The intended patient population is the general population requiring such procedures.

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This document is a 510(k) premarket notification decision letter from the FDA regarding a dental handpiece, specifically the 23:1 Reduction Angle. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does not contain any information regarding acceptance criteria, device performance results, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, adjudication methods, or MRMC studies. The document is a regulatory approval letter, not a study report.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about a study proving the device meets the criteria based solely on the provided text.

The information present in the document is:

• Device: 23:1 Reduction Angle (Dental Handpiece)
• Applicant: Midwest Dental Products
• FDA K Number: K973800
• Regulatory Class: I
• EGS Product Code: EGS
• Indications for Use: To provide a dental professional a low-speed handpiece for various dental procedures including, but not limited to, Prophy, Post and Pin Drilling, Pin Setting, Root Canal Enlargement and Sealing, and Caries Removal for the general patient population.
• Decision: Substantially equivalent.

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MicroJet System is an AC-powered cavity preparation device. The device uses air-driven particles to roughen the surfaces of dental restorations. MicroJet System is intended as an ancillary device for removing tooth structure, and restorative dental materials as well as preparing teeth for dental restoration.

MicroJet System is an AC-powered cavity preparation device. The device uses air-driven particles to roughen the surfaces of dental restorations.

This document is a marketing clearance letter from the FDA for a dental device, the Microjet Cavity Preparation System. It is not a study report and therefore does not contain the detailed information requested regarding acceptance criteria and study results.

The letter confirms that the device is "substantially equivalent" to devices marketed prior to 1976. This determination is based on a 510(k) submission, which typically involves demonstrating equivalence to a predicate device rather than conducting a de novo clinical study with specific acceptance criteria and detailed performance metrics as would be found in a research paper.

Therefore, I cannot provide the requested information based on the provided text.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device