(77 days)
The Impact Air 45 Handpiece for Periodontal Use is an air-powered dental handpiece intended for use in osteoplasty (bony contouring), odontoplasty, root resection, and other periodontal procedures for which a conventional handpiece would be used.
The Impact Air 45 Handpiece for Periodontal Use is an air-powered dental handpiece intended for use in osteoplasty (bony contouring), odontoplasty, root resection, and other periodontal procedures for which a conventional handpiece would be used. The handpiece is intended to provide a better work environment than a conventional high-speed, air-powered handpiece in that (1) it is designed so that air is not directed onto the area of the bur and (2) it is designed with a 45-degree back-angled head shank to facilitate access.
The device is intended for use with all friction-qrip burs, including surqical length burs, that conform to I.S.O. and A.D.A. shank diameter standards (0.0626 to 0.0630 inches). The recommended operating air pressure is between 32 and 40 pounds per square inch ("psi"), which results in high-speed bur rotation (approximately 400,000 to 500,000 revolutions per minute ("rpm")). The device includes a water line that directs water onto the spinning bur, which forms a cooling mist and also helps irrigate the working area. The use of sterile water is recommended. One model of the device also includes a fiberoptic bundle that directs light onto the working area.
The device may be connected to a standard compressed air source found in virtually all dental units. The use of filtered air is recommended. The air supply enters the device through a tube in the handle and turns the turbine, which is in the head of the device, thus spinning the bur. The air exits the device principally through an air exhaust tube in extes the device portion of the air exits through the the handro. Ear and of the device. Virtually no air exits from the front of the head into the area of the bur.
The Impact Air 45 can be sterilized by autoclave when prorne impact in inutes at 250 degrees. Data indicate that after 250 sterilization cycles the handpiece continues to function appropriately.
This looks like a 510(k) premarket notification for a dental handpiece, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, experts, and MRMC studies is not applicable in the context of this document.
The document describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices. It states that the device is intended for use in osteoplasty, odontoplasty, root resection, and other periodontal procedures. The performance claims focus on its design features (air not directed onto the bur, 45-degree angle for access) and mechanical characteristics (operating air pressure, RPM, cooling mist, sterilization).
The "study" mentioned for this device is primarily focused on sterilization durability:
- Acceptance Criteria/Performance: After 250 sterilization cycles, the handpiece continues to function appropriately.
- Study Type: Durability testing (mechanical/sterilization cycles).
- Sample Size for Test Set: Not explicitly stated, but implies at least one handpiece was subjected to 250 cycles.
- Data Provenance: Not explicitly stated, but would be internal testing by the manufacturer.
- Experts/Ground Truth: Not applicable for this type of mechanical testing. The "ground truth" is whether the device still functions as intended.
- Adjudication Method: Not applicable.
- MRMC Study: Not applicable.
- Standalone Performance: The sterilization test is a standalone performance test of the device's durability.
- Ground Truth Type: Functional performance (i.e., does it still operate correctly after sterilization?).
- Training Set Sample Size/Ground Truth: Not applicable, as this is not an AI/ML device requiring a training set.
The core of this 510(k) submission relies on substantial equivalence to predicate devices, asserting that it has the same intended use, does not raise new questions of safety or effectiveness, and is fundamentally similar in principle, design, materials, energy source, and other characteristics to known devices.
In summary, for K972376, the requested AI/ML-related information is not present or applicable. The relevant "study" information pertains to mechanical durability.
§ 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.