(114 days)
ND lowspeed airmotor, MP-50M, is used to power prophy angle attachment that helps dental clinician perform the hygiene dentistry work such as cleaning. The device is autoclavable.
ND low speed airmotor, MS-10M / MS-55M, are used to power attachment that helps dental clinician perform various dental work such as cleaning, tooth carving, others. The device is autoclavable.
ND star-type straight nosecone attachment, STS-30H, is powered by either lowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. The device is autoclavable.
ND star-type contra angle attachment, STC-20L / STU-20ML / STU-30BLP, are powered by either lowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. The device is autoclavable
ND highspeed airturbine handpiece, TCP-70QM / TCP-70QB / TC-80QB, are air-powered dental handpiece for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restoration and polishing teeth. The device is autoclavable.
Not Found
This document is a 510(k) premarket notification from the FDA, determining substantial equivalence for dental handpieces and accessories. It does not describe an AI/ML-driven medical device or a study proving its performance against acceptance criteria.
The information you are asking for, such as acceptance criteria, sample sizes for test/training sets, expert qualifications, ground truth establishment, or multi-reader multi-case (MRMC) studies, is not present in this type of regulatory document. This document is related to traditional medical devices (dental handpieces) and their substantial equivalence to previously marketed devices based on their intended use and technological characteristics, not on software performance or clinical study results for novel AI algorithms.
Therefore, I cannot provide the requested information based on the provided text.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.