(127 days)
The turbine handpiece is intended for the following applications: Removal of decayed materials, cavities and crown preparation, removal of fillings, finishing of tooth and restoration surfaces.
The dental handpiece/contra-angle is intended for the following applications: Removal of decayed materials, cavities and crown cement, removal of fillings, finishing and polishing of tooth and restoration surfaces.
The Air-Powered Handpieces and the Handpiece Attachments are reusable, ergonomically shaped and some of them include LED light system.
The submission is comprised of:
• The W&H Synea Vision/Fusion Air-Powered Handpieces: TK-100 L, TK-100 LM, TK-98 L, TK-98 LM, TK-97 L, TK-97 LM, TK-94 L, TK-94 LM, TG-97, TG-97 L, TG-97 LM, TG-97 L RM, TG-97 L N, TG-98, TG-98 L RM, TG-98 LM, TG-98 L N
• The W&H Alegra Air-Powered Handpieces: TE-97 LQ, TE-98 LQ, TE-95 RM, TE-97, TE-97 RM, TE-98, TE-98 RM
• The W&H Air Motors: AM-25 A RM, AM-25 E RM, AM-25 RM, AM-20 E RM, AM-20 RM
• The W&H Roto Quick couplings: RQ-04, RQ-14, RQ-24, RQ-34, RQ-54, RM-34 LED G
• The W&H Synea Fusion Handpiece Attachments: HG-43 A, WG-56 LT, WG-56 A, WG-66 LT, WG-66 A, WG-99 LT, WG-99 A
• The W&H Synea Vision Handpiece Attachments: HK-43 LT, WK-99 LT, WK-99 LT S, WK-93 LT S, WK-93 LT, WK-56 LT, WK-56 LT S, WK-66 LT, WK-66 LT S
• The W&H Alegra Handpiece Attachments: HE-43, HE-43 T, WE-56, WE-57, WE-57 T, WE-56 LED G, WE-66 LED G, WE-99 LED G
The Air-powered Handpieces contain pipes inside which supply air for driving the turbine's impeller as well as supply air and water for creating spray exhausting through 3, 4 or 5 ports located in the handpiece's head and intended for cooling the working area as well as the rotating bur. Depending on the type of handpiece – the handle might contain an integrated circuit board and wire bundles, for supplying current and voltage to a head-sided assembled LED light source.
The Handpiece Attachments also contain pipes inside which supply air and water for spray exhausting and for cooling the working area as well as the rotating bur.
Depending on the type of handpiece – the handle might contain an integrated circuit board and wire bundles, for supplying current and voltage to a head-sided assembled LED light source.
The provided text is a 510(k) summary for W&H Air-Powered Handpieces and Handpiece Attachments, indicating their substantial equivalence to predicate devices. It describes the device, its intended use, and comparisons to predicate devices based on technical characteristics and performance testing. However, this document does not contain information regarding the acceptance criteria for an AI/ML medical device, nor does it detail a study proving such a device meets acceptance criteria.
The document explicitly states: "Clinical data were not needed for this new product." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance through clinical studies or specific acceptance criteria for AI/ML algorithms.
Therefore, I cannot fulfill the request as it pertains to AI/ML device acceptance criteria and study details based on the provided text. The document describes a traditional medical device (dental handpieces) and its clearance process, not an AI/ML device.
§ 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.