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K Number
K984609
Device Name
ADEC DENTAL UNIT, MODELS CENTURY PLUS & CASCADE, DCI DENTAL UNIT, MODEL SERIES III
Manufacturer
LITE SPECIALTY METAL WORKS, INC.
Date Cleared
1999-02-09

(43 days)

Product Code
EIA
Regulation Number
872.6640
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The LSM Dental Unit is intended to supply power to and serve as a base for other dental services. The Dental Operative Unit includes an automatic control system, a water control for hand pieces and syringes, a 3 way syringe, instrument holder, mounting, vacuum system, foot control and utility box.

Device Description

The LSM Dental Unit is intended to supply power to and serve as a base for other dental services. The Dental Operative Unit includes an automatic control system, a water control for hand pieces and syringes, a 3 way syringe, instrument holder, mounting, vacuum system, foot control and utility box.

AI/ML Overview

This document is an FDA 510(k) clearance letter for the "ADEC Dental Unit, Models Century Plus & Cascade, DCI Dental Unit" with product code EIA. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain the information necessary to describe acceptance criteria, a study proving device adherence, or any of the detailed points requested in your prompt (sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth types for training/testing, or training set size/ground truth establishment).

The document is purely a regulatory clearance. It does not elaborate on the performance evaluation or testing used to achieve this clearance. For that information, you would typically need to refer to the actual 510(k) submission document itself, which is not provided here.

§ 872.6640 Dental operative unit and accessories.

(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.