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ZX-27 is a preformed anchor, designed to be incorporated into a dental appliance, such as a denture, to help stabilize the appliance in the patient's mouth.

ZX-27 is a preformed anchor, designed to be incorporated into a dental appliance, such as a denture, to help stabilize the appliance in the patient's mouth.

I am sorry, but based on the provided text, there is no information about the acceptance criteria and the study that proves the device meets those criteria for the "ZX-27" preformed anchor.

The document is a 510(k) clearance letter from the FDA to M&M Dental Studio Incorporated for their device, ZX-27. This type of letter indicates that the FDA has found the device to be substantially equivalent to a legally marketed predicate device, primarily based on its indications for use and general safety/effectiveness considerations, rather than specific performance study data outlined in the typical format you've requested.

The document mentions:

• Device Name: ZX-27
• Regulation Number: 21 CFR 872.3130
• Regulation Name: Preformed Anchor
• Regulatory Class: I (indicating lower risk, often cleared based on general controls and substantial equivalence to existing devices)
• Indications for Use: "ZX-27 is a preformed anchor, designed to be incorporated into a dental appliance, such as a denture, to help stabilize the appliance in the patient's mouth."

However, it does not include:

• A table of acceptance criteria or reported device performance.
• Details of any specific studies (sample sizes, data provenance, ground truth, expert opinions, adjudication methods, MRMC studies, or standalone performance).
• Information about training sets or how their ground truth was established.

This document is primarily an administrative clearance letter, not a detailed technical report of a performance study.

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