Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device