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The Acclaim system is primarily a tool to provide visual information to dental patients so that they can better understand the necessity and quality of the health care they receive.

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This is a notification about the clearance of the Acclaim system, a dental operative unit, and accessories. Due to the nature of the document, there is no information regarding the acceptance criteria, study details, or device performance as it would be found in a clinical study report. The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to legally marketed devices.

The key information provided is:

• Trade/Device Name: Acclaim
• Regulation Number: 21 CFR 872.6640
• Regulation Name: Dental Operative Unit and Accessories
• Regulatory Class: I
• Product Codes: NRD and EAY
• 510(k) Number: K042266
• Indications for Use: The Acclaim system is primarily a tool to provide visual information to dental patients so they can better understand the necessity and quality of the healthcare they receive. This is the same intended use as previously cleared for the VistaCam Omni IC, 510(k) number K974204.

Since this is a Class I device and a 510(k) clearance, a full clinical study with specific acceptance criteria and detailed performance metrics is often not required, especially if the device is found to be substantially equivalent to a predicate device. The substantial equivalence is typically based on technological characteristics and intended use.

Therefore, I cannot provide the detailed information requested in the prompt based on the provided FDA clearance letter.

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