(52 days)
The ProSmile Air Polisher is intended for removing deposits, plaque, and staining on all visible tooth surfaces as well as in fissures and interdental areas. The ProSmile is also intended for the following prophylactic applications:
- cleaning teeth prior to scaling
- cleaning teeth prior to fluoridation
- cleaning teeth prior to bleaching
- cleaning teeth prior to using bonding materials .
The ProSmile consists of the handpiece, ProSmile Prophylaxis Powder, the powder jet nozzle, test card, and hose coupling. The components that are integral to the C8+ Dental Operative Unit and used during ProSmile operation are the powder chamber. powder chamber venting button, water regulator, air/powder regulator, and foot control. The ProSmile is a pneumatically operated device that is offered with two powder jet nozzles.
The provided text describes a 510(k) submission for the Sirona Dental Systems ProSmile Air Polisher and Prophylaxis Powder. It outlines the device's intended use, description, and basis for substantial equivalence to a predicate device.
However, the document does not contain specific acceptance criteria or a detailed study proving the device meets performance criteria beyond a general statement about functional testing and risk analysis.
Therefore, I cannot provide the requested information in the format specified because the necessary details are not present in the given text.
Here's why and what information is available:
Missing Information:
- Specific Acceptance Criteria: The document does not list quantitative or qualitative acceptance criteria for the device's performance (e.g., a specific percentage of plaque removal, a certain level of stain reduction, or a maximum abrasion level).
- Detailed Study Data: While it states "Functional testing" was conducted and "results confirmed that the ProSmile is safe and effective," no details of this functional testing are provided. This includes:
- Reported Device Performance: No specific metrics or results are given.
- Sample Size: No information on the number of subjects, teeth, or procedures used in any test.
- Data Provenance: No mention of the origin of data (e.g., clinical trials, in-vitro experiments, country of origin).
- Experts for Ground Truth: No mention of experts, their qualifications, or their role in establishing ground truth.
- Adjudication Method: Not applicable as there's no expert assessment described.
- MRMC Comparative Effectiveness Study: No such study is mentioned. The comparison is primarily structural and functional similarity to a predicate device.
- Standalone Performance: No specific standalone performance metrics are provided.
- Type of Ground Truth: Not described as there's no detailed study.
- Training Set Sample Size: No training set is mentioned, as this appears to be a device performance evaluation (design verification/validation), not an AI/algorithm-based diagnostic device.
- Ground Truth for Training Set: Not applicable.
Information Present (but not directly answering the full request):
- Intended Use: Removing deposits, plaque, and staining, and for prophylactic applications (cleaning prior to scaling, fluoridation, bleaching, bonding).
- Basis for Substantial Equivalence: Visual and operational similarity to the EMS Air Flow Handy 2 Air Polisher and Powder (K022119). Both use a mixture of water, air, and powder for dental cleaning.
- Performance Testing Mentioned: "The appropriate design verification and design validation activities were conducted to address the potential risks identified in the Hazard Analysis. These activities included electrical safety testing, electromagnetic compatibility testing, and functional testing. The results confirmed that the ProSmile is safe and effective for its intended use." This is a high-level summary without any specifics.
In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence to a predicate device through general design and safety testing, rather than a detailed clinical or performance study report with specific acceptance criteria and detailed performance metrics.
§ 872.6080 Airbrush.
(a)
Identification. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.(b)
Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”