(39 days)
Fuji II is a self-cure glass ionomer material intended for the use as a dental restorative for the following typical applications:
- Restoration of primary teeth.
- Core build-ups.
- Class III, V and limited Class I cavities.
Fuji II is a self-cure glass ionomer material.
The provided text is an FDA 510(k) clearance letter for a dental restorative material called "Fuji II". This document confirms the device's substantial equivalence to a predicate device and allows it to be marketed.
However, this document does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria.
The letter only states:
- Trade Name: Fuji II
- Regulatory Class: II
- Product Code: EMA
- Indications For Use: Restoration of primary teeth, Core build-ups, Class III, V and limited Class I cavities.
- Substantial Equivalence: The FDA has determined the device is substantially equivalent to devices marketed prior to May 28, 1976.
To answer your request, information regarding performance data, testing methods, sample sizes, ground truth establishment, or expert involvement would need to be found in the actual 510(k) submission document itself, which is not provided here. The clearance letter only references the submission and its outcome.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3
Ms. Terry L. Joritz · Director-Regulatory Affairs & Quality Control Official Correspondent GC AMERICA INCORPORATED 3737 West 127th Street Alsip, Illinois 60803
Re: K980682 Trade Name: Fuji II Regulatory Class: II Product Code: EMA Dated: February 19, 1998 February 23, 1998 Received:
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 reqistration, 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. ਚ 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 requlation (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
Tim Wlodkowski
Time 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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为
INDICATIONS FOR USE
Device Name: Fuji II
Indications For Use: Fuji II is a self-cure glass ionomer material intended for the use as a dental restorative for the following typical applications:
- · Restoration of primary teeth.
- Core build-ups. .
- Class III, V and limited Class I cavities. .
Susan Puno
(Division Sign-Off) Division of Denial, Infection Control, and General Hospital Devices 510(k) Number KAX
§ 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.