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K Number
K983285
Device Name
ENGLE DENTAL FAMILY OF DELIVERY SYSTEMS
Manufacturer
ENGLE DENTAL SYSTEMS
Date Cleared
1998-11-04

(47 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 Engle Dental Systems Family of Dental Units are medical devices to be used by dentists, and hygienists in the procedures they perform. The Engle Dental Systems Family of Dental Units feature numerous attachments and suction instruments. The Engle Dental Systems Family of Dental Units utilize foot controls, assistant's arms, and were to taster to the hand pieces that operate demal handpock the dentists use in the procedures they periodi on the stanges as Upits feature numerous attachments and su fion instruments. The Eligie Domar Dyschall foot controls, assistant's arms.

Device Description

Dental units

AI/ML Overview

This 510(k) summary (K983285) for Engle Dental Systems Family of Dental Units does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.

The document is a premarket notification to the FDA, asserting substantial equivalence to a predicate device. It includes:

  • Applicant Information: Engle Dental Systems, Inc. Contact person Marvin Fox.
  • Date Prepared: August 31, 1998.
  • Trade Name: Engle Dental Systems Family of Dental Units.
  • Unit Styles and Part Numbers: A table listing various delivery systems (AS-1, AS-2, EDS-1, ME-2, ME-2 Control Head Only, Micro II Miniature Control) and their respective part numbers. It notes that the differences in part numbers are primarily cosmetic and not technological.
  • Common Name and Classification Name: Dental units, classified as Operative, dental (per 21 CFR 872.6640).
  • FDA Response Letter: Dated November 4, 1998, stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls.
  • Indications for Use: States that the Engle Dental Systems Family of Dental Units are medical devices to be used by dentists and hygienists in the procedures they perform, operating dental handpieces and featuring numerous attachments and suction instruments. It also explicitly states that the device is substantially equivalent to the 1400 XL Deluxe Dental Delivery System manufactured by Summit Dental Systems.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details because it is not present in the provided text. This type of document (510(k) summary) typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria.

§ 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.