MIRACLE MIX CAPSULE

K981370 · GC America, Inc. · EMA · Jun 1, 1998 · Dental

Device Facts

• Record ID: K981370
• Device Name: MIRACLE MIX CAPSULE
• Applicant: GC America, Inc.
• Product Code: EMA · Dental
• Decision Date: Jun 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Miracle Mix is a self cure silver alloy glass ionomer cement intended for use as a dental restorative available in premeasured single use capsules.

Device Story

Miracle Mix is a self-curing silver alloy glass ionomer cement provided in premeasured single-use capsules. Used by dental professionals in a clinical setting for dental restorations. The material is mixed and applied to the tooth cavity to restore structure and function. It serves as a restorative dental cement, providing a durable filling material for patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Silver alloy glass ionomer cement; self-curing; supplied in premeasured single-use capsules.

Indications for Use

Indicated for use as a dental restorative material in patients requiring dental fillings or restorations.

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

JUN 1 1698

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

K981370 Re : Miracle Mix Capsule Trade Name: Regulatory Class: II Product Code: EMA Dated: April 13, 1998 Received: April 15, 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 able beach in the 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 regulation may result in regulatory 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 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 [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

Timbythy A. Ulatows 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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## INDICATIONS FOR USE

Device Name:

Miracle Mix Capsule Modification

## Indications for Use:

Indications for Use: Miracle Mix is a self cure silver alloy glass ionomer cement intended for use as a dental restorative available in premeasured single use capsules.

Susan Runge

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