(186 days)
IS USED TO MIX WITH A SILVER-TIN-COPPER POWDER ALLOY TO MAKE A DENTAL AMALGAM AND THEN TO FILL DENTAL CAVITIES
Not Found
This document is a 510(k) premarket notification decision letter from the FDA regarding a dental amalgam. It does not contain information about the acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot extract the requested information from the provided text.
The letter simply states that the FDA has reviewed the notification for the device named "Mercury Dental" and determined it to be "substantially equivalent" to devices marketed prior to May 28, 1976. This substantial equivalence determination allows the company, Aleaciones Dentales Zeyco, S.A. de C.V., to market the device.
The document provides the following details, but none are related to device performance studies or acceptance criteria:
- Trade Name: Mercury Dental
- Regulatory Class: I
- Product Code: ELY
- Indications For Use: "IS USED TO MIX WITH A SILVER-TIN-COPPER POWDER ALLOY TO MAKE A DENTAL AMALGAM AND THEN TO FILL DENTAL CAVITIES"
§ 872.3070 Dental amalgam, mercury, and amalgam alloy.
(a)
Identification. Dental amalgam is a device that consists of a combination of elemental mercury, supplied as a liquid in bulk, sachet, or predosed capsule form, and amalgam alloy composed primarily of silver, tin, and copper, supplied as a powder in bulk, tablet, or predosed capsule form, for the direct filling of carious lesions or structural defects in teeth. This device also includes the individual component devices, mercury and amalgam alloy, when intended to be combined with each other to form dental amalgam.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.”See § 872.1(e) for the availability of this guidance document.