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K Number
K152125
Device Name
Oral Surgery System and Accessories
Manufacturer
BONART CO., LTD.
Date Cleared
2016-08-15

(381 days)

Product Code
DZI
Regulation Number
872.4120
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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

Device Description

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

AI/ML Overview

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.

§ 872.4120 Bone cutting instrument and accessories.

(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.