LogoFDA 510(k) Search
K Number
K070537
Device Name
ZIRBLOCK
Manufacturer
CDL TECHNOLOGIES INC.
Date Cleared
2007-04-30

(63 days)

Product Code
EIH
Regulation Number
872.6660
Type
Traditional
Panel
DE
Reference & Predicate Devices
K053438,K052130,K061851
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

ZirBlock® is used in the manufacture of dental prosthetics: crowns, bridges, inlays, and onlays.

Device Description

ZirBlock® is a pre-formed material for use by dental laboratories in filling orders/prescriptions for dental prosthetics

AI/ML Overview

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

The document is a 510(k) summary for a dental material called ZirBlock®. It focuses on demonstrating substantial equivalence to predicate devices (other legally marketed dental materials) rather than presenting performance data against defined acceptance criteria.

Here's why I cannot provide the requested information:

  • No Acceptance Criteria Defined: The summary states: "None required. The claim of substantial equivalence is based on comparisons of formulations, mechanical characteristics, and intended uses of the devices to legally marketed predicates and to the IDENTIFICATION of porcelain powders in 21 CFR 872.6660." This explicitly states that performance data against acceptance criteria was not required for this submission.
  • No Performance Study Described: The document mentions "comparisons of formulations, mechanical characteristics, and intended uses," but it does not detail any specific study design, methodology, results, or statistical analysis that would constitute a "study that proves the device meets the acceptance criteria."
  • Focus on Substantial Equivalence: The entire submission is built around the concept of substantial equivalence to existing predicate devices, meaning the device is considered as safe and effective as devices already on the market, without necessarily requiring a new, independent performance study against novel acceptance criteria.

Therefore, since the input document does not contain the information you've requested, I cannot complete the table or answer the specific questions about sample size, expert ground truth, adjudication, or MRMC studies.

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.