STRONG Dental Handpieces

• K Number: K181129
• Device Name: STRONG Dental Handpieces
• Manufacturer: Saeshin Precision Co., Ltd.
• Date Cleared: 2019-01-31 ( 276 days)
• Product Code: EGS
• Regulation Number: 872.4200
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

The Strong Dental Handpiece, ACL(B)-46EP is intended for wide range of dental procedures, including:

A. Implant placement, including

• 1. Preparation of the osteotomy site
• 2. Bone contouring, osteoplasty
• B. Periodontal surgeries
• 1. Bone contouring & alveoplasty around living teeth
• 2. Removal of exostosis
• C. Bone grafting
• 1.Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
• 2. Harvesting autogen living bone
• 3. Sinus elevation & grafting of alveolar sockets

D. Removal and sectioning of teeth and teeth bone for e.g. impacted third molars and complicated extractions.

Device Description

Not Found

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria.

The document is a 510(k) clearance letter from the FDA for a medical device called "STRONG Dental Handpieces". It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general controls provisions of the Act that the manufacturer must comply with. It also includes an "Indications for Use" section for the device.

Therefore, I cannot provide the requested information based on the given input.

Regulation Number and Section

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.