(49 days)
Fuji I is a self-cure glass ionomer material intended for the use as a luting cement for cementation of inlays, crowns, bridges and orthodontic bands.
Fuji I is a self-cure glass ionomer material.
The provided document is a 510(k) clearance letter from the FDA for a medical device called "Fuji I," issued in 1998. This type of document declares substantial equivalence to a predicate device and permits marketing. It outlines the intended use of the device.
However, the document does not contain the detailed information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or clinical study methodologies. The FDA 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical performance studies with detailed statistical analysis as might be found for novel, high-risk devices or software as a medical device (SaMD) clearances today.
Therefore, I cannot populate the requested information from the provided text. The document is too old and not detailed enough to address these modern requirements for a device performance study.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of curved lines and shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Terry L. Joritz ·Director-Regulatory Affairs & Quality Control Official Correspondent GC AMERICA INCORPORATED 3737 West 127th Street Alsip, Illinois 60803
APR 1 3 1998
K980695 Re : Trade Name: Fuji I Requlatory Class: II Product Code: EMA February 19, 1998 Dated: Received: February 23, 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 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
{1}------------------------------------------------
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) 638-2047 or (301) 443-6597 or at
its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, " and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
INDICATIONS FOR USE
Device Name: FUJI I
Indications For Use: Fuji I is a self-cure glass ionomer material intended for the use as a luting cement for cementation of inlays, crowns, bridges and orthodontic bands.
Susan Rumsey
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number 2980095
§ 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.