(76 days)
The Concentrix High-Speed Handpieces are used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparations.
The Concentrix High-Speed Handpieces are pneumatically driven, hand-held devices used by trained dental professionals to perform a variety of dental procedures.
The Concentrix MX is a non-fiber optic, 2/3 line fixed backend handpiece with a steel bearing manual chucking turbine. The Concentrix PX is a non-fiber optic, 2/3 line fixed backend handpiece with a steel bearing, push button autochuck turbine. The Concentrix FX is a non-fiber optic, 3/4 line fixed backend handpiece with a steel bearing, push button autochuck turbine. The Concentrix SX is a fiber optic, swivel handpiece with a steel bearing, push button autochuck turbine.
This document describes a 510(k) Premarket Notification for the DentalEZ, Inc. Concentrix High-Speed Handpiece Series. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the typical sense of a diagnostic or AI-powered device.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable to this type of regulatory submission, as it is not an AI/diagnostic device.
The "acceptance criteria" here are effectively the criteria for demonstrating substantial equivalence to the predicate device.
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission for a dental handpiece, "acceptance criteria" are implied by demonstrating that the new device has the same technological characteristics, intended use, and performance as the predicate device, or that any differences do not raise new questions of safety and effectiveness.
| Acceptance Criterion (Implied for Substantial Equivalence) | Reported Device Performance / Assessment |
|---|---|
| Intended Use | The Concentrix High-Speed Handpieces are used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparations. This is identical to the predicate device. |
| Technological Characteristics | Pneumatically driven, hand-held devices. Three models are non-fiber optic with fixed backend; one model (SX) is fiber optic with swivel connector. All incorporate steel bearing turbines requiring lubrication. MX uses a manual chucking mechanism; PX, FX, and SX use push-button autochuck. These characteristics are stated to be the same as the predicate devices, with design similarities noted for the specific models' features (e.g., fiber optic, chucking mechanism). |
| Design | Stated as "Similar" to the predicate device, implying that any differences in design are not considered to raise new questions of safety or effectiveness. |
| Materials | Stated as "Similar" to the predicate device, implying that any differences in materials are not considered to raise new questions of safety or effectiveness. |
| Performance | Stated as "Similar" to the predicate device. This implies that the device operates and functions effectively for its intended use, comparable to the predicate. Specific quantifiable performance metrics (e.g., RPM, torque) are not detailed in this summary but would have been part of the full submission to justify "Similar." |
| Sterility | Stated as "Identical" to the predicate device. |
| Biocompatibility | Stated as "Identical" to the predicate device. |
| Mechanical Safety | Stated as "Identical" to the predicate device. |
| Chemical Safety | Stated as "Identical" to the predicate device. |
| Energy Used/Delivered | Stated as "Identical" to the predicate device. |
| Compatibility with environment & other devices | Stated as "Identical" to the predicate device. |
| Where Used | Stated as "Identical" to the predicate device. |
| Standards Met | Stated as "Similar" to implicitly indicate compliance with relevant standards, similar to the predicate device. Specific standards are not listed in this summary but would be in the full submission. |
| Electrical Safety | Stated as "Not applicable" as these are pneumatically driven handpieces. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission for a mechanical dental instrument, not a diagnostic or AI device that relies on a test set of patient data. The "study" here is a comparison to a predicate device based on engineering and design characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth for a diagnostic test set is not relevant to this device. The assessment is based on engineering evaluations and comparison to the predicate device characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is for diagnostic studies with human readers.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this submission is the performance and safety profile of the legally marketed predicate device (Star Dental 430 Series High Speed Handpiece, K960719), as established through its prior clearance and market history. The substantial equivalence relies on demonstrating that the new device is as safe and effective as this predicate.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning 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.