(86 days)
NATURA teeth are to be used in conjunction with denture base resin for the construction of full and partial dentures. For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding "Natura Denture Teeth" and an "Indications For Use" statement. It 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 for an AI/CAD medical device.
Therefore, I cannot extract the requested information from the given input. The document is a regulatory approval letter for a dental product, not a technical report on a diagnostic device's performance.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 1999
Davis Schottlander & Davis, Ltd. C/O Mr. Clyde E. Ingersoll CEI Enterprises 54 Riverview Avenue Tonawanda, New York 14150-5260
K984134 Re : Natura Denture Teeth Trade Name: Regulatory Class: II Product Code: ELM October 28, 1998 Dated: Received: November 18, 1998
Dear Mr. Ingersoll:
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
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Page 2 - Mr. Ingersoll
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 diaqnostic 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.fday.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 Radioloqical Health
Enclosure
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Davis Schottlander & Davis Ltd
Dunhams Lane, Letchworth, Herts SG6 1NS, England +044 (0)1462 480848 Phone: +044 (0)1462 482802 FAX:
510 (k)
ATTACHMENT #4
Schottlander NATURA denture teeth
INDICATIONS FOR USE
Device Name: Schottlander NATURA denture teeth
NATURA teeth are to be used in conjunction with denture base resin for the construction of full and partial dentures.
For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.
Davis Schottlander & Davis Ltd
Lceadea
Mohamed K Ladha Quality Assurance manager
Prescription Uco ............................................................................................................................................................. (Per Zi erk odi. 109)
Susan Rurang
Division Sign-Off) Division of Dental, Infection Control and General Hospital Devices 510(k) Numbe
§ 872.3590 Preformed plastic denture tooth.
(a)
Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.