(49 days)
ENIGMA denture base is to be used in conjunction with denture teeth in 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.
Schottlander ENIGMA HI-BASE Denture base material
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication method, MRMC study, standalone performance, training set details), or the type of ground truth used.
The document is an FDA 510(k) clearance letter for a dental device (Enigma Hi Base Denture-Base Material), indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and compliance requirements. Attachment #4 provides the "INDICATIONS FOR USE" for the device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 1999
Davis Schottlander & Davis Limited c/o Mr. Clyde E. Ingersoll Official Correspondent Davis Schottlander & Davis Limited CEI Entrprises 54 Riverview Avenue Tonawanda, NY 14150-5260
Re : K993717 Eniqma Hi Base Denture-Base Material Trade Name: Regulatory Class: II Product Code: EBI Dated: October 18, 1999 Received: November 3, 1999
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 of the Act. The general controls provisions 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 Regulations, Title 21, Parts 800 to 895. ਮ 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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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 regulations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA findinq 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
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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Davis Schottlander & Davis Ltd
Dunhams Lane, Letchworth, Herts SG6 1NS, England +044 (0)1462 480848 Phone: +044 (0)1462 482802 FAX:
ATTACHMENT #4 510 (k) Schottlander ENIGMA HI-BASE Denture base material INDICATIONS FOR USE
Device Name: Schottlander ENIGMA HI-BASE Denture base material
ENIGMA denture base is to be used in conjunction with denture teeth in 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
Liciada
Mohamed K Ladha Quality Assurance manager
Prescription Use (Per 21 CFR 801.109)
Susan Runser
(Division Sign-Off) Division of Dental, Infection Control, and General Hospita 510(k) Number .
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.