APEX LOCATOR BINGO-1020

• K Number: K992233
• Device Name: APEX LOCATOR BINGO-1020
• Manufacturer: DENT CORP. RESEARCH & DEVELOPMENT
• Date Cleared: 1999-11-30 ( 158 days)
• Product Code: LQY
• Regulation Number: N/A
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

BINGO-1020 is a modern device for precise apex localization during root channel treatment.

Device Description

BINGO-1020 is distinguished by increasing precision at 0.1mm on wet/dry, large graphic display where current position of endo file is reflected and other essential information is displayed.

AI/ML Overview

I'm sorry, but the provided text from the FDA 510(k) clearance letter for the Apex Locator Bingo-1020 does not contain information about acceptance criteria or a study proving the device meets those criteria.

The letter focuses on the FDA's determination of substantial equivalence to a predicate device, which allows the device to be marketed. It does not include details about device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request for the specific information outlined in points 1 through 9 based on the provided document.

Regulation Number and Section

N/A