(459 days)
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.
§ 872.3130 Preformed anchor.
(a)
Identification. A preformed anchor is a device made of austenitic alloys or alloys containing 75 percent or greater gold or metals of the platinum group intended to be incorporated into a dental appliance, such as a denture, to help stabilize the appliance in the patient's mouth.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.