(49 days)
- Class III and V restorations; particularly areas of cervical erosion, a. abfraction lesions and root surface caries.
- Restoration of primary teeth b.
- As a base or liner C .
- Core build-ups/block-outs (particularly of vital teeth) ర .
- Cases in which a radiopaque restoration is required e .
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details. The document is an FDA 510(k) clearance letter for the Fuji II LC Capsule, which is a dental material. It confirms that the device is substantially equivalent to a legally marketed predicate device and lists its indications for use.
Therefore, I cannot extract any of the requested information regarding acceptance criteria or a study proving device performance from this document.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the top half of the circle. Inside the circle is an image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 1 2000
Mr. Terry L. Joritz GC America, Incorporated 3737 West 127th Street Chicago, Illinois 60658
Re: K993973 Fuji II LC Capsule Trade Name: Requlatory Class: II Product Code: EBF Dated: November 18, 1999 Received: November 23, 1999
Dear Mr. 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ದ 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
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Page 2 - Mr. Joritz
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 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.qov/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
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Page 8 of 8
K993973
(443973 510(k) Number (if known):
Fuji II LC Capsule Device Name:
Indications For Use:
- Class III and V restorations; particularly areas of cervical erosion, a. abfraction lesions and root surface caries.
- Restoration of primary teeth b.
- As a base or liner C .
- Core build-ups/block-outs (particularly of vital teeth) ర .
- Cases in which a radiopaque restoration is required e .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)
Susan Russo
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.