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K Number
K093341
Device Name
CENTURY MODEL 105C
Manufacturer
SYBRON DENTAL SPECIALTIES, INC.
Date Cleared
2010-04-05

(164 days)

Product Code
EFB
Regulation Number
872.4200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K073478
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Century 105C Handpieces are intended for the removal of carious material, cavities and crown preparations, removal of fillings, and processing of tooth and restoration surfaces. They are designed for use by a trained professional in the field of general dentistry.

Device Description

The Century 105C Handpieces are dental instruments for use by a trained professional in general dentistry. The handpieces are powered by pneumatic pressure on a rotor with roller bearings. The devices are re-usable and ergonomically shaped, and can be sterilized by the steam autoclave method.

AI/ML Overview

This document provides a 510(k) summary for the KaVo Century 105C handpiece. This is a premarket notification for a dental device, not a study evaluating acceptance criteria of a device through clinical trials or performance testing with specific metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information is not applicable to this document.

The document discusses:

  • Device Name: KaVo Century 105C
  • Intended Use: Removal of carious material, cavities and crown preparations, removal of fillings, and processing of tooth and restoration surfaces.
  • Substantial Equivalence: Claimed substantial equivalence to the Kaltenbach & Voigt GmbH, SUPERtorque Air-Driven Highspeed Handpieces (K073478). This means the manufacturer believes the new device is as safe and effective as a legally marketed predicate device.
  • Regulatory Clearance (FDA): The FDA reviewed the 510(k) and determined the device is substantially equivalent to a predicate device, allowing it to be marketed.

This 510(k) summary is a regulatory filing, not a performance study report.

§ 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.