(155 days)
intended for use during dental and periodontal therapy treatments to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.
an ultrasonic scaler intended for use during dental and periodontal therapy treatments to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.
This document (K964596) is a 510(k) premarket notification for an ultrasonic scaler, a device used in dentistry to remove calculus. It does not contain any information about acceptance criteria, device performance metrics (like accuracy, sensitivity, specificity), data provenance, expert ground truth, or details of a study involving AI or human readers.
The document primarily focuses on establishing "substantial equivalence" of the new device (Pro-Select3™) to existing predicate devices (like Dentsply's Cavitron® Ultrasonic 3000) for the purpose of regulatory approval. This type of submission typically demonstrates that the new device has the same intended use and similar technological characteristics, and does not raise new questions of safety or effectiveness, without necessarily providing detailed performance studies in the way you've outlined for AI/ML device evaluations.
Therefore, I cannot provide the requested table and study details based on the provided text. The document is for a traditional medical device and does not involve the type of performance evaluation typically associated with AI/ML systems.
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C. EXECUTIVE SUMMARY
APR 22 1997
1. Reason for Submission
Premarket notification, as required under Section 510(k) of the Federal Food, Drug, and Cosmetic (FD&C) Act, facilitates the marketing of medical devices that are "new" to a company but substantially equivalent to devices that are already legally marketed. This submission provides the premarket notification required by section 510(k) of the Act and 21 CFR $807.87
2. Description
The device for which 510(k) recognition of substantial equivalence is sought is an ultrasonic scaler intended for use during dental and periodontal therapy treatments to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.
3. Substantial Equivalence
Comparison in terms of "substantial equivalence" is made to other marketed devices. Professional Dental Manufacturing, Inc.'s device is substantially equivalent to predicate devices because it has the same intended use as a host of ultrasonic scalers, in particular, Dentsply's Cavitron® Ultrasonic 3000, 1010 and 660 Scalers, Johnson & Iohnson's Alfa-Sonic Hygienic Scaler Model 300 and Healthco's Air Flow II Scaler. For purposes of this PMN, we will compare the Pro-Select3TM to the Cavitron® Model 3000.
This PMN establishes that the Pro-Select;3™ is substantially equivalent to the predicate device in its respective ability to remove calculus deposits from the teeth. Furthermore, this PMN establishes that Pro-Select3™s technological characteristics are similar enough to the Cavitron® devices that it will not affect safety and effectiveness.
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.