MERCURY DENTAL by ALEACIONES DENTALES ZEYCO, S.A. DE C.V.

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"

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 1998

Dr. Jorge Zepeda Galvez -----Managing Director Aleaciones Dentales Zeyco, S.A. de C.V. Calzada Lazaro Cardenas #2838 Col. Jardines Del Bosque Guadalajara, Jal. C.P.44520

K973548 Re : Trade Name: Mercury Dental Regulatory Class: I Product Code: ELY Dated: March 14, 1998 Received: March 16, 1998

Dear Dr. Jorge Zepeda Galvez:

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, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A . . . . . substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in this response to your the Federal Register. Please note: premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Dr. Jorge Zepeda Galvez

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page Page -ੀ

973548 510(k) Number (if known):

Device Name: MERCURY

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

Image /page/2/Picture/5 description: The image shows a document with the text "FDA/CDRH/ODE/DMC" written diagonally. Next to it, the date "16 MAR 98" is written. Below the date, the number "1416" is written. The word "REVIEWED" is written vertically on the left side of the image.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumer

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109) Yes

Over-The-Counter Use No

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.