(86 days)
This device, an air-powered, fiber optic, swivel air scaler, is intended for use to remove calculus deposits and stains from a tooth, as done in normal dental scaling operation . The device uses controlled water spray and an appropriate scaling tip to wash away removed calculus and stains.
air-powered, fiber optic, swivel air scaler
Unfortunately, the provided document is a 510(k) clearance letter from the FDA for a "Sonic Scaler with Fiber Optic." This type of document primarily confirms that the device is substantially equivalent to existing devices and can be marketed.
It does NOT contain the detailed information required to answer your questions about acceptance criteria and a study proving the device meets those criteria.
Specifically, the document does not include:
- A table of acceptance criteria or reported device performance.
- Information about sample sizes, data provenance, or expert qualifications for a test set.
- Details on adjudication methods, MRMC studies, or standalone performance.
- The type of ground truth used or information about a training set.
To obtain this information, you would typically need to refer to the device's 510(k) submission summary, engineering reports, or peer-reviewed studies related to the device, which are not part of this FDA clearance letter.
§ 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.