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CLEARFIL DC CEMENT is indicated for the following applications:

• Porcelain inlay cementation 1)
• Composite resin inlay cementation 2)
• Jacket crown cementation with porcelain or composite resin 3)

CLEARFIL DC CEMENT is a dual-cure composite resin cement and used as a cement to affix dental appliances such as crowns. This product is classified into the dental cement other than zinc oxide-eugenol, 21 C.F.R. Section 872.3275.

The provided document is a 510(k) summary for a dental device, "CLEARFIL DC CEMENT." This document focuses on a change in manufacturer and asserts that the device is "substantially equivalent" to a previously cleared predicate device (K980232).

Crucially, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through empirical data analysis.

The 510(k) submission states that: "This device is essentially the same as CLEARFIL DC CEMENT manufactured by Kuraray Co., Ltd. (K980232). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CLEARFIL DC CEMENT." This implies that the performance data from the predicate device's clearance would be referenced, but no such data, acceptance criteria, or study details are present in this specific document.

Therefore, I cannot provide the requested information from this document. If these details were available, they would typically be found in sections describing performance testing, clinical studies, or bench testing results which are absent here.

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• 1. Porcelain inlay cementation
• 2. Composite resin inlay cementation
• 3. Jacket crown cementation with porcelain or composite resin

Not Found

The provided text is a 510(k) clearance letter from the FDA for a dental cement product called "CLEARFIL DC Cement." This document does not contain information about acceptance criteria or a study proving device performance.

510(k) clearances are based on demonstrating substantial equivalence to a predicate device, not on meeting specific performance criteria demonstrated through clinical studies in the same way a PMA (Premarket Approval) would require. The letter confirms that the device is "substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976."

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) from the provided document. This type of information would typically be found in a separate study report or regulatory submission, not in the FDA clearance letter itself.

Ask a specific question about this device