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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.

Dental units

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.

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