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510(k) Data Aggregation
(210 days)
Dental High-speed Handpiece and Accessories
The Dental High-speed Handpiece Halley Series is intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.
The Dental High-speed Handpiece Halley Series is a hand-held instrument which propelled by a small air-powered turbine (or rotor), capable of high speed, which is integrated into the head of the handpiece and has a chucking device coaxial with the turbine. The main materials of the dental handpiece and accessories are stainless steel. Rotation speed range is around 330,000-390,000 rpm. Our couplings are in compliance with the Type 1, Type 3 of the recognized standard ISO 9168 Hose connectors for air driven dental handpieces, and vary with the most famous brands in the world.
This document is a 510(k) premarket notification for a Class I medical device, specifically a Dental High-speed Handpiece Halley Series. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific clinical performance against acceptance criteria in the way an AI/ML device would. Therefore, many of the requested categories related to AI/ML device studies (like sample sizes for test sets, expert adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this submission.
However, I can extract the information relevant to device performance and acceptance criteria as presented in a substantial equivalence context.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (a dental handpiece), "acceptance criteria" are generally derived from recognized medical device standards and comparisons to predicate devices. The performance data presented focuses on technical specifications that demonstrate equivalence.
| Characteristic | Acceptance Criteria (from Predicate/Reference Devices & Standards) | Reported Device Performance (Dental High-speed Handpiece Halley Series) |
|---|---|---|
| Indications for Use | Removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations, and polishing teeth. For trained professionals in general dentistry. (Identical to predicate and reference devices). | Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations, and for polishing teeth. Designed for use by a trained professional in the field of general dentistry. |
| Rotation Speed | Predicate: 340,000-400,000 rpm; Reference: 320,000-400,000 rpm (at recommended drive air pressure). | 330,000-390,000 rpm (at the recommended drive air pressure) |
| Bur Type | ISO 1797-1 ø 1.59 ~ 1.60 mm Standard Bur (Implicitly shared with predicate/reference as compliance to ISO 1797-1 is stated.) | ISO 1797-1 ø 1.59 ~ 1.60 mm Standard Bur |
| Max. Bur Length | Not explicitly stated for predicates, but 21 mm is a common spec. | 21 mm |
| Recommended Drive Air Pressure | Predicate: 41 psi; Reference: Identical. | 40 psi |
| Operating Drive Air Pressure | Predicate: 30-61 psi; Reference: Identical. | 36-43 psi |
| Max. Air Consumption | Not explicitly stated for predicates, but generally below a threshold. |
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