(47 days)
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.
Miracle Mix is a self cure silver alloy glass ionomer cement intended for use as a dental restorative available in premeasured single use capsules.
This document is a 510(k) clearance letter from the FDA for a dental restorative device called "Miracle Mix Capsule Modification." It signifies that the device is substantially equivalent to a predicate device already on the market.
However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The letter primarily focuses on:
- Device Identification: Miracle Mix Capsule Modification
- Regulatory Classification: Class II
- Product Code: EMA
- Date of Clearance: June 1, 1998
- 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."
- General Controls: The device is subject to general controls provisions of the Act, including annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
Therefore, I cannot provide the requested table and information as the source document does not contain this type of data.
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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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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
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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Image /page/2/Picture/0 description: The image shows a handwritten sequence of characters. The sequence starts with the letter 'K', followed by the numbers '9', '8', '1', '3', '7', and '0'. The characters are written in a simple, clear style, making them easily readable.
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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
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)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.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. 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.(2)
Classification. Class II.