(47 days)
Aseptico's fully autoclavable handpieces are used for a wide range of dental procedures including;
- Dental endodontic surgeries, such as drilling into the root canal.
- General dentistry, such as removing carious material from the dentine.
- Performing dental implant surgeries, such as perforating the bone, and tapping and threading procedures required before placement of implant prosthetics.
Aseptico's autoclavable handpieces are intended to be used by dental professionals for a broad range of intra-oral dental procedures. These handpieces integrate requirements specified in International Standard ISO 7785-2 "Dental handpieces - Part 2: Straight and geared angle handpieces". This standard describes in precise detail how dental handpieces are typically designed and should perform, including withstanding a minimum of 250 cycles of steam autoclaving.
Aseptico's autoclavable dental handpieces vary from one model to another in three fundamental ways: They have different gear ratios, different methods for attaching burs and files (latch or push button style), and may be either straight or angled. The most common and notable variation between Aseptico's handpieces are their gear ratios. Different handpiece ratios convert the same input rotational force of an electric micro-motor into different bur speeds and bur torque. Aseptico's handpieces use a different arrangement of geared components to obtain different ratios of input to output speeds. These ratios are represented by numbers ranging from 1:1 (no reduction) to a 256:1 reduction.
All Aseptico's dental handpieces are tested and validated by a third party laboratory to a sterility assurance level (SAL) of 10-6. Every handpiece is designed to ensure that the innermost, hardest to reach parts of the handpieces are sterile when following sterilization procedure included in the instructions for use.
The provided text is a 510(k) summary for Aseptico Autoclavable Handpieces. It describes the device, its intended use, and states that it integrates requirements specified in international standard ISO 7785-2. It also mentions testing by a third-party laboratory for sterility assurance, but it does not contain information about acceptance criteria, specific study designs, sample sizes, expert involvement, or any performance metrics in the format requested.
Therefore, I cannot provide the detailed information requested in the table and subsequent points based on the provided text.
The document primarily focuses on:
- Description of the Device: Dental handpieces with various gear ratios, bur attachment methods, and straight/angled designs.
- Intended Use: Broad range of intra-oral dental procedures including endodontic surgeries, general dentistry (removing carious material), and dental implant surgeries (perforating bone, tapping/threading).
- Compliance with Standards: Conforms to ISO 7785-2 (Dental handpieces - Part 2: Straight and geared angle handpieces) for design and performance, including withstanding a minimum of 250 cycles of steam autoclaving.
- Sterilization: Tested by a third-party laboratory to a sterility assurance level (SAL) of 10⁻⁶.
- FDA Clearance: A 510(k) premarket notification was reviewed, and the device was determined to be substantially equivalent to legally marketed predicate devices.
§ 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.