(47 days)
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No
The document describes a dental cement and contains no mention of AI, ML, or any related technologies.
No
The device is a dental restorative material, which is used to repair or replace damaged tooth structure, not to diagnose, cure, mitigate, treat, or prevent disease.
No
Explanation: The device is a dental restorative cement, not a diagnostic tool. Its purpose is to restore teeth, not to identify or diagnose medical conditions.
No
The device description clearly states it is a "self cure silver alloy glass ionomer cement," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a dental restorative". This means the device is used directly on the patient's teeth to restore their structure and function.
- Device Description: The description confirms it's a "self cure silver alloy glass ionomer cement intended for use as a dental restorative".
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition
- Being used in a laboratory setting
IVDs are used to perform tests on samples taken from the body to provide diagnostic information. This device is used in the body to repair teeth.
N/A
Intended Use / 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.
Product codes
EMA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
dental
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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 (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