MIRACLE MIX POWDER/LIQUID

K984505 · GC America, Inc. · EMA · Feb 4, 1999 · Dental

Device Facts

• Record ID: K984505
• Device Name: MIRACLE MIX POWDER/LIQUID
• Applicant: GC America, Inc.
• Product Code: EMA · Dental
• Decision Date: Feb 4, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Miracle Mix is a powder and liquid self cure silver alloy glass ionomer cement intended for core build ups, restoration of primary teeth, as a base or a liner, for Class I, limited class II, temporary fillings and in cases where radiopacity is required.

Device Story

Miracle Mix is a self-cure silver alloy glass ionomer cement. It is used by dental professionals in a clinical setting for restorative procedures, including core build-ups, primary tooth restoration, and as a base or liner. The device is supplied as a powder and liquid system that is mixed by the clinician to form a restorative material. It provides radiopacity for diagnostic purposes. The material is placed into the tooth cavity or core area to restore structure or provide a foundation for further dental work. It benefits patients by providing a durable, radiopaque restorative option for various dental indications.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Self-cure silver alloy glass ionomer cement consisting of a powder and liquid component. The material is designed for dental restorative applications requiring radiopacity.

Indications for Use

Indicated for core build-ups, restoration of primary teeth, base or liner, Class I and limited Class II restorations, temporary fillings, and cases requiring radiopacity.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 4 1999

Ms. Terry L. Joritz Director-Regulatory Affairs & Quality Control Official Correspondent GC AMERICA INCORPORATED 3737 West 127th Street Alsip, Illinois 60803

K984505 Re : Miracle Mix Powder/Liquid Trade Name: Requlatory Class: II Product Code: EMA December 16, 1998 Dated: Received: December 18, 1998

Dear Ms. Joritz:

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, Drug, 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 regulations 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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Ms. Joritz

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 & bling 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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K984505

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## INDICATIONS FOR USE

Miracle Mix Powder/Liquid Modification Device Name: _

Indications for Use: Miracle Mix is a powder and liquid self cure silver alloy glass ionomer cement intended for core build ups, restoration of primary teeth, as a base or a liner, for Class I, limited class II, temporary fillings and in cases where radiopacity is required.

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510(k) Number _