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Bonart dental hand piece is used for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations.

Bonart Dental Handpieces (ART), Disposable Prophy Angle (PERFORMANCE)

The provided text is a 510(k) summary from the FDA for Bonart Dental Handpieces (ART) and Disposable Prophy Angle (PERFORMANCE). It is a letter of substantial equivalence and does not contain details about acceptance criteria, study methodologies, or performance results. This document is a regulatory approval, not a scientific study report.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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The Bonart Oral Surgery System is intended for use in oral surgery and dental implantology,

ARTeotomy ORAL SURGERY SYSTEM and ACCESSORIES (Model No. BIS)

The provided FDA document, K152125 for the "ARTeotomy Oral Surgery System and Accessories (Model No. BIS)", is a 510(k) premarket notification and focuses on establishing substantial equivalence to a predicate device. This type of document does not contain details about acceptance criteria, specific device performance metrics, or study designs (including sample sizes, ground truth establishment, or expert involvement) typically found in clinical validation studies for AI/software-as-a-medical-device (SaMD) products.

The document primarily states that the device is intended for "oral surgery and dental implantology" and has been determined to be substantially equivalent to a legally marketed predicate device.

Therefore, based solely on the provided text, I cannot extract the requested information. The document serves as an FDA clearance letter, not a detailed study report.

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The ART-IM1 Implantor is an implant machine system. It is primarily used by dental professionals in doing oral implant surgery or implantology such as drilling, reaming, cutting, etc. This system is also used for fixing previous broken or failed implant procedure.

BonartART-IM1 Implantor System & Accessories

The provided text describes a 510(k) premarket notification for a dental implant machine system, the BonartART-IM1 Implantor System & Accessories. It establishes substantial equivalence to a predicate device based on its indications for use.

However, the document is a regulatory approval letter and an indication for use statement. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the detailed study parameters requested in your prompt.

Therefore, I cannot populate the requested information from the provided text. The document is concerned with regulatory approval based on substantial equivalence, not a detailed performance study as would be seen for AI/ML devices or novel diagnostic tools.

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ART-L5 LED Cordless Curing Light System is used in light polymerization of dental composite and curing dental restorative thru source of illuminations.

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This document is a 510(k) clearance letter from the FDA for a dental curing light, the BONART ART-L5 LED Cordless Curing Light. It primarily addresses regulatory approval based on "substantial equivalence" to a predicate device, rather than providing details of a study with specific acceptance criteria and performance metrics for a novel AI or medical imaging device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment is not available in the provided text.

The document confirms that:

• Device Name: BONART ART-L5 LED Cordless Curing Light System
• Indications For Use: Used in light polymerization of dental composite and curing dental restorative through a source of illuminations.
• Regulatory Class: II
• Product Code: EBZ (Ultraviolet Activator for Polymerization)

The FDA's review determined the device is substantially equivalent to legally marketed predicate devices. This means that Bonart Company, Limited did not need to conduct a new clinical trial or extensive performance study demonstrating compliance with a specific set of acceptance criteria in the same way a novel high-risk device might. Instead, they demonstrated that their device performs as safely and effectively as an already-approved device.

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ART-P31! Pro Multi-function piezoelectric Ultrasonic system is intended for use by medical professionals during denral cleaning and periodontal therapy to remove calculus and tartar deposits and stains from teeth using the application of an ultrasonically vibrating frequency through a stainless steel t p dental accessory called "Tip". Tip comes in various shapes (BS1, BS2, B53 etc.) and is designed to generate a vibrating frequency of 29Khz.

ART-M311 Pro Multi-function-Magnet Ultrasonic System is intended for use by medical professionals during demal cleaning and periodontal therapy to remove calculus and tartar deposits and stains from teeth using the application of an ultrasonically vibrating frequency through a stainless steel tip dental accessory called "Insert comes in various shapes (ART P-10, ART SLI-P100, ART IF50 etc.) and is designed to generate a vibrating frequency of 24.5KHz. ±5%.

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The provided document is a 510(k) premarket notification letter from the FDA for a dental ultrasonic scaler. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test sets.
3. Number or qualifications of experts used for ground truth.
4. Adjudication methods.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
6. Information about standalone algorithm performance.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory approval letter based on substantial equivalence to predicate devices, not a detailed report of performance studies against specific acceptance criteria.

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The ARTeotomy Ultrasonic surgery system (OP1) uses piezoelectric ultrasonic technology to generate mechanical micro vibrations for bone cutting, with minimal soft tissue trauma. The system is supplied with sharp, smoothing and blunt insert tips for dental oral surgery use, including implantology, periodontal surgery and surgical orthodontics. Piezo tips come in various shapes and forms (BS-OTI, BS-OT3, BS-OT5 etc.) and are designed to generate a vibrating frequency of 26-32 kHz

The ARTeotomy Ultrasonic Surgery System (OM1) uses magnetostrictive ultrasonic technology to generate mechanical micro vibrations for bone cutting, with minimal trauma to soft tissue. The system is supplied with sharp, smoothing and blunt insert for dental oral surgery use, including implantology, periodontal surgery and surgical orthodontics. Inserts come in various shapes and forms (ART-AS, ART-LH, ART-LV etc.) and are designed to generate a vibrating frequency of 24.5 kHz.

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I am sorry, but the provided text is a 510(k) summary letter from the FDA to Bonart Company, Limited, regarding their Bonart-ARTeotomy Ultrasonic Surgery System. It details the FDA's determination of substantial equivalence for the device based on its indications for use.

This document does not contain any information about acceptance criteria, device performance tables, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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ART-P6 Piczo Electric Ultrasonic Scaler is intended for use by medical professionals during dental cleaning and periodontal therapy to remove calculus and tartar deposits and stains from teeth using the application of an ultrasonically vibrating frequency through a stainless steel tip dental accessory called "Tip". Tip comes in various shapes (BS1, BS2, BS3 etc.) and is designed to generate a vibrating frequency of 29Khz,

BONART ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS)

This document is a 510(k) premarket notification letter from the FDA regarding the Bonart Art-P6 Piezo Electric Ultrasonic Scaler & Accessories (Tips). It does not contain information about acceptance criteria, device performance studies, or ground truth establishment.

Therefore, I cannot provide the requested information. The letter only states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not include details of performance testing or clinical studies that would be necessary to answer your questions.

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Source of illumination for curing dental is restorative materials.

BONART ART-L3 LED CURING LIGHT

This letter is a 510(k) clearance for a dental curing light, a device whose performance is assessed through physical characteristics rather than diagnostic accuracy. Therefore, the questions related to AI/algorithm performance (such as acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) are not applicable in this context.

Summary of the Device:

• Trade/Device Name: BONART ART-L3 LED CURING LIGHT
• Regulation Number: 872.6070
• Regulation Name: Ultraviolet Activator for Polymerization
• Regulatory Class: II
• Product Code: EBZ
• Indication for Use: Source of illumination for curing dental restorative materials.

The FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market subject to general controls provisions of the Act.

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BONART's ART-P3II & ART-P4 Piezo Ultrasonic Scaler are intended for use by medical professionals during dental cleaning and periodontal therapy to remove calculus and tartar deposits and stains from teeth using the application of an ultrasonically vibrating frequency through a stainless steel tip dental accessory called "Tip". Tips come in various shapes (BS1, BS2, BS3 etc.) and are designed to generate a vibrating frequency of 29Khz.

BONART ART-P3II PIEZO ULTRASONIC SCALER & ACCESSORIES (TIPS) BONART ART-P4 PIEZO ULTRASONIC SCALER & ACCESSORIES (TIPS)

The provided text is an FDA 510(k) clearance letter for an ultrasonic scaler. It does NOT contain any information about acceptance criteria or a study proving device performance against such criteria.

The document primarily states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It lists the device name, regulation number, regulatory class, and product code. It also includes an "Indications for Use" statement.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study to prove the device meets them, as this data is entirely absent from the provided text.

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Ask a specific question about this device