Search Results

HYDRORISE is conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient 's teeth and gums.

HYDROSYSTEM, an accessory to Hydrorise dental impression material, is intended to be applied to conventional substrates, including tooth preparations, ceramics, composites, metal core build-up material, and provides a uniform surface wetting with reduced surface tension beliore applying traditional dental impression material.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets those criteria.

The document is a 510(k) premarket notification letter from the FDA to Zhermack S.P.A. for their devices HYDRORISE and HYDROSYSTEM. It states that the devices are substantially equivalent to legally marketed predicate devices. It also outlines regulatory requirements such as registration, labeling, and good manufacturing practices.

Specifically, the document contains:

• Dates: March 26, 2009 (FDA letter date), March 17, 2009 (Applicant's letter date), March 19, 2009 (Received date), November 03, 2008 (HYDRORISE revision date).
• Device Names: HYDRORISE and HYDROSYSTEM.
• Regulation Number: 21 CFR 872.3660 (Impression Material).
• Regulatory Class: II.
• Product Code: ELW.
• Indications for Use:
  • HYDRORISE: "conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums."
  • HYDROSYSTEM: "an accessory to Hydrorise dental impression material, is intended to be applied to conventional substrates, including tooth preparations, ceramics, composites, metal core build-up material, and provides a uniform surface wetting with reduced surface tension before applying traditional dental impression material."

There is no mention of:

• Acceptance criteria for performance.
• Any study (e.g., clinical, technical) conducted by the manufacturer to demonstrate performance.
• Sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for any such study.

Therefore, I cannot provide a table of acceptance criteria and device performance, nor can I describe study details as requested.

Ask a specific question about this device