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The device is intended for use in general dental applications, where high speed cutting is required, such as cutting a tooth for crown preparation, cavity preparation, removing metal crown or fillings. In addition to above Indication for Use, we would like to emphasize, as a USA-patented, long proven dust shield mechanism, Clean-Head System, is used as an integral part of the turbine cartridge, that this device is able to substantially reduce bacterial contamination of the handpiece exhaust air lines to the dental unit.

Air Turbine Handpiece, Mach-Sigma Ultra Push

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental handpiece. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. Therefore, I cannot fulfill your request based on the given input.

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This device, an air-powered, fiber optic, swivel air scaler, is intended for use to remove calculus deposits and stains from a tooth, as done in normal dental scaling operation . The device uses controlled water spray and an appropriate scaling tip to wash away removed calculus and stains.

air-powered, fiber optic, swivel air scaler

Unfortunately, the provided document is a 510(k) clearance letter from the FDA for a "Sonic Scaler with Fiber Optic." This type of document primarily confirms that the device is substantially equivalent to existing devices and can be marketed.

It does NOT contain the detailed information required to answer your questions about acceptance criteria and a study proving the device meets those criteria.

Specifically, the document does not include:

• A table of acceptance criteria or reported device performance.
• Information about sample sizes, data provenance, or expert qualifications for a test set.
• Details on adjudication methods, MRMC studies, or standalone performance.
• The type of ground truth used or information about a training set.

To obtain this information, you would typically need to refer to the device's 510(k) submission summary, engineering reports, or peer-reviewed studies related to the device, which are not part of this FDA clearance letter.

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The device is a control unit that drives a dc electric micromotor and turns on or off the motor by its foot switch. It is intended for use in general dental applications for work such as cutting a tooth for crown preparation, cavity preparation, finishing the crown, inlay or the filling, polishing, prophylaxis and endodontic treatment, with use of a straight, right-angle or contra-angle ISO E-type attachment of equal speed, speed increasing or decreasing sheath. The micromotor speed is adjustable by the control knob on the front face of the control unit from 2,000 to 30,000 rpm.

The device is a control unit that drives a dc electric micromotor and turns on or off the motor by its foot switch. The micromotor speed is adjustable by the control knob on the front face of the control unit from 2,000 to 30,000 rpm.

The provided text is a 510(k) premarket notification approval letter for a dental device, "Elec-Mate". It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document only confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed subject to general controls.

Therefore, I cannot provide the requested information.

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This device, a small, battery-powered, light-weight, low-speed electric motor handpiece, runs at 200 rpm to 2000 rpm, and is intended for use in light general dental, prophylaxis, or endodontic works, where low speed is required.

a small, battery-powered, light-weight, low-speed electric motor handpiece, runs at 200 rpm to 2000 rpm. A variety of detachable heads, each of which is pushed into or pulled out of the motor handpiece, are available to perform required job, such as a prophy head for screw-in or snap-on prophy cups and brushes, a latch head for latch reamer or latch file, a 1/4-turn head, up-down head, 10:1 reduction speed head, etc.

The provided text is an FDA 510(k) clearance letter for a dental device, the "PROPHY-MATE Motor Handpiece." This type of document is a regulatory approval, not a scientific study report. As such, it does not contain any of the requested information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or specific study methodologies.

The letter explicitly states that the device is deemed "substantially equivalent" to devices marketed prior to May 28, 1976. This means the FDA's decision is based on a comparison to existing, legally marketed predicate devices, rather than requiring new clinical trials or performance studies with acceptance criteria as one would find for a novel device.

Therefore, I cannot provide the requested information from the given text.

Here's a breakdown of why this information is missing:

• Acceptance Criteria and Reported Device Performance: Not included. The letter is about regulatory clearance based on substantial equivalence, not a detailed performance report.
• Sample Size and Data Provenance: Not applicable to this type of regulatory submission. The substantial equivalence pathway typically relies on existing knowledge and comparison to predicate devices, not new sample-based studies.
• Number of Experts and Qualifications: Not mentioned. Expert review in this context would be part of the FDA's internal process for assessing the 510(k) submission against the predicate device, not for establishing ground truth in a clinical study.
• Adjudication Method: Not applicable. There's no clinical trial data with adjudication described.
• Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned and highly unlikely for a device seeking 510(k) clearance through substantial equivalence for a basic dental handpiece.
• Standalone (algorithm only) Performance: Not applicable, as this is a mechanical dental handpiece, not an AI or algorithm-driven device.
• Type of Ground Truth Used: Not applicable. There's no clinical study described that would require a ground truth.
• Sample Size for Training Set: Not applicable, as there's no machine learning model or algorithm being trained.
• How Ground Truth for Training Set was Established: Not applicable.

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The device is a dc electric micromotor driven by the battery power pack control device with emphasis in mobility to visit schools, nursing homes, house calls, and for emergency need.

It is intended for use in general dental applications for light work such as cutting a tooth for crown preparation, cavity preparation, finishing the crown, inlay or the filling, polishing, and endodontic treatment, with use of straight, right-angle or contra-angle ISO E-type attachment.

The device is a dc electric micromotor driven by the battery power pack control device with emphasis in mobility to visit schools, nursing homes, house calls, and for emergency need.

This document is a 510(k) clearance letter from the FDA for a dental device called "Handy-Mate," issued on March 19, 1999. It states that the device is substantially equivalent to legally marketed predicate devices.

This document does NOT contain information about acceptance criteria, device performance, sample size, ground truth establishment, or any study details. It is a regulatory clearance, not a technical performance report. Therefore, I cannot extract the requested information from the provided text.

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The device is intended for use in general dental applications, where high speed cutting is required; such as cutting a tooth for crown preparation, cavity preparation, removing metal crown or fillings.

This device uses a USA-patented, long proven check valve, a Non-Retraction Valve, in the water line of the handpiece to prevent the oral fluids, which could be contaminated, from being drawn into the handpiece spray port(s) of the handpiece. The contaminants could reach beyond the handpiece, but this check valve, as being installed in the handpiece body, prevents them from reaching beyond the handpiece.

Air Turbine Handpiece, MACH-Sigma (Σ) Ultra-Push

This document is a 510(k) clearance letter from the FDA for a dental handpiece. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory obligations.

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

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The device is a control unit intended to drive contra angles and other attachments that are used with appropriate burs and drills for drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of dental, oral surgical and other small surgical procedures.

The device is a control unit intended to drive contra angles and other attachments that are used with appropriate burs and drills for drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of dental, oral surgical and other small surgical procedures. The control unit is equipped with a roller pump to deliver saline solution or sterile water as irrigant to the handpiece. The electric micromotor and its cord are not autoclavable; therefore, adequate covering by plastic sleeving as commonly used in dental for infection control method is necessary. The irrigation tube set used between the irrigation nozzle at the handpiece and the saline solution bottle via roller pump is supplied as an accessory item in the control unit package. It is ETO sterilized for 10 ° sterility, pyrogen-free. The control unit has risk of explosion if used in the presence of flammable anesthetics.

The provided document is a 510(k) premarket notification letter from the FDA for a dental surgical control unit (Surgic II Implant Control Unit). This type of document primarily confirms substantial equivalence to a predicate device and allows marketing. It does not contain acceptance criteria or study results as typically found in clinical trial reports or performance testing summaries.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the criteria. The document focuses on regulatory approval based on "substantial equivalence" rather than detailed performance reporting against pre-defined acceptance criteria from a specific study.

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The device is intended for use where high speed such as 200,000 rpm is required in general dentistry with or without use of coolant; such as cutting a tooth for cavity and/or crown preparation and finishing, cutting and/or finishing of dentures, denture bases, crowns, inlays and metal plates. The device is driven by an electric micromotor or an air motor handpiece that has the ISO-3964 Coupling.

E-Type Speed Increaser Contra Angle, ES-95

This document is a 510(k) clearance letter from the FDA for a dental device. It does not contain information regarding acceptance criteria, a study proving performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Therefore, I cannot fulfill your request using the provided text. The document's purpose is to state that the device is substantially equivalent to legally marketed predicate devices and can now be marketed, not to detail the performance studies and criteria.

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The devices claimed hereis are the air turbines only, and are not the handpiece itself.

The devices are intended for use in the Miwest's Quiet-Air or Tradition handpieces, in place of Midwest's original turbines.

The device, therefore, is, with Midwest handpiece, intended for use in general dental applications; such as cutting a tooth for crown preparation, cavity preparation, finishing the crown, inlay or the filling, etc.

NSK Pushbutoon Autochuck Replacement Turbine. The devices claimed hereis are the air turbines only, and are not the handpiece itself.

The provided document is a 510(k) clearance letter from the FDA for a dental turbine. It is a regulatory approval document and does not contain information about acceptance criteria or a study proving device performance as would be found in a clinical trial report or a detailed technical submission.

Therefore, I cannot extract the requested information from the provided text. The document confirms that the "NSK Push-Button Midwest Replacement Turbine" is substantially equivalent to legally marketed predicate devices and outlines the indications for use. It does not include data on acceptance criteria, device performance, sample sizes for testing or training, expert qualifications, or ground truth methodologies.

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Ask a specific question about this device