SONIC AIR MM1500 + (MID), MODEL 50400014

• K Number: K081268
• Device Name: SONIC AIR MM1500 + (MID), MODEL 50400014
• Manufacturer: MICRO-MEGA SOCIETE ANONYME
• Date Cleared: 2009-08-10 ( 462 days)
• Product Code: ELC
• Regulation Number: 872.4850
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

Endodontics

canal preparation -

canal cleaning

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is an FDA 510(k) clearance letter for the "Sonic Air MM 1500+ (MID)" device, indicating that it has been found substantially equivalent to a predicate device for endodontic canal preparation and cleaning.

The letter discusses regulatory compliance requirements but does not detail any performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert involvement as requested in your prompt. These details would typically be found in the 510(k) submission summary or associated testing reports, which are not included in this document.

Regulation Number and Section

§ 872.4850 Ultrasonic scaler.

(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.