(329 days)
Dental Handpiece with models of SG200, SG200L, SA100L, SA100R, CA100L, and CA100R are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.
In addition, Dental Handpiece with models of SG200, SG200L are also intended for implant surgery such as perforating the bone, tapping and threading procedures.
Dental Handpiece is designed for use by a trained professional in the field of general dentistry.
Dental Handpiece with models of SG200, SG200L, SA100L, SA100R, CA100L, and CA100R are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.
In addition, Dental Handpiece with models of SG200, SG200L are also intended for implant surgery such as perforating the bone, tapping and threading procedures.
Dental Handpiece is designed for use by a trained professional in the field of general dentistry.
The proposed dental handpiece consists of the main body of a handpiece, which is used for transmitting a rotational force for the general dental treatments as well as accessory components. which are used for channeling water and air for further applications to the dental treatments. The torque transmitted from an electric micro-motor gets further transmitted to the joint part of Dental Handpiece. The rotational force is then decelerated according to the speed reducer of the gear to be transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism.
The product is offered as an electrical-powered Dental Handpiece that is reusable and ergonomically shaped. The dental handpiece can be sterilized by the steam autoclave method. Through the tube and the electrical motor connected to a dental unit, the Dental Handpiece equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) receive the energy for the gear, the cooling water and air for cutting treatment. Dental burs and other attachments will be used with the proposed Dental Handpiece per ISO 1797:2017 (Dentistry - Shanks for rotary and oscillating instruments).
Dental Handpiece has been developed with a full range of surgical contra angle intended to be used in implantology. The contra angle-design, size and performance of the proposed Dental Handpiece conform to ISO 14457 (2017) "Dentistry -Handpieces and motors"
The six (6) product codes and models of Dental Handpiece are SG200L, SG200, CA100L, CA100R. SA100L. SA100R.The component names and functional descriptions for critical components of Dental Handpiece are provided in the table below.
The provided text describes a 510(k) premarket notification for a Class I dental handpiece, meaning it is seeking to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving a specific performance metric against acceptance criteria. Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, expert involvement, etc.) is not explicitly available in the provided document in the way it would be for a novel device undergoing clinical trials.
The document focuses on demonstrating that the new dental handpiece is substantially equivalent to existing predicate devices (SMARTmatic (K163239) and ANTHOGYR Contra angles and Handpieces (K093894)). Substantial equivalence is primarily proven by showing similar indications for use and technological characteristics, and by conforming to recognized standards.
Here's an analysis of the provided information relative to your request:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria in the sense of specific thresholds for a novel device's performance metrics (e.g., a specific accuracy or sensitivity). Instead, it lists design verification and performance data tests that were conducted to confirm the device meets pre-determined design requirements and conforms to recognized standards. The "reported device performance" is generally stated as "favorable test results" or "demonstrates conformance."
Here's a table based on the information available, interpreting "acceptance criteria" as meeting the relevant standard and "reported device performance" as the outcome of the testing:
| Acceptance Criteria (Interpreted as Conformance to Standard) | Reported Device Performance (as stated in document) |
|---|---|
| Biocompatibility: Conformance to ISO 10993-1:2009 for tissue/bone/dentin contact with limited |
§ 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.