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• Identification: A base metal alloy is a device composed of a material such as a Amixture of Nickel and Chromium
• Intended Use: This material is to be used by the dentist in the fabrication of Ba custom-made dental device, such as a porcelain veneer for a tooth.
• Classifcation: Class II C-

Ceradium V Non-Precious Ceramic Alloy

The provided document is a 510(k) clearance letter from the FDA for a dental alloy, Ceradium V Non-Precious Ceramic Alloy. This document does not contain any information about acceptance criteria or a study proving device performance. It only states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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• Identification: A base metal alloy is a device composed of a material such as a mixture of Nickel and Chromium
• Intended Use: This material is to be used by the dentist in the fabrication of a custom-made dental device, such as a porcelain veneer for a tooth.
• Classification: Class II

Hi Bond Non-Precious Ceramic Alloy is a base metal alloy composed of a material such as a mixture of Nickel and Chromium.

The provided text is a 510(k) clearance letter from the FDA for a dental alloy, specifically "Hi Bond Non-Precious Ceramic Alloy." This document does not contain any information about acceptance criteria, device performance studies, or clinical trial data.

The letter is a regulatory document confirming that the device is "substantially equivalent" to devices already on the market, which is a different concept than providing evidence of performance through a study described in the prompt's request.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on equivalence, not on specific performance metrics or studies as outlined in your prompt.

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The provided text is an FDA 510(k) clearance letter for a "Ceradium Non-Precious Ceramic Alloy." This type of document does not contain details about acceptance criteria or a study proving device performance in the way a medical device efficacy or AI performance study report would.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined 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..."

This means the device was cleared based on its substantial equivalence to a previously legally marketed device, not on a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria. The FDA's 510(k) process for this type of device typically relies on demonstrating that the new device has "the same intended use as the predicate device" and "the same technological characteristics as the predicate device" or "different technological characteristics from the predicate device" but that "the new device does not raise different questions of safety and effectiveness than the predicate device" and "the new device is as safe and effective as the predicate device."

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) from this document because it is not present. This document is a regulatory approval letter, not a device performance study report.

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The Intended Use: This material is to be used by the dentist to produce an impression of a person's mouth/teeth and then a plaster material is poured into this impression to create a cast of the patient's mouth/ teeth.

Kromatica Color Changing Alginate

This document is a 510(k) clearance letter from the FDA for the "Kromatica Color Changing Alginate" impression material (K974894). It states that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria, specific performance metrics, or study details.

Therefore, I cannot provide the requested information. The document focuses solely on the regulatory clearance for marketing based on substantial equivalence. It does not include data from a clinical or performance study that would define acceptance criteria or device performance.

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