(83 days)
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No
The document describes denture teeth and does not mention any software, image processing, or AI/ML terms.
No
The device, "ENIGMA teeth," is described as being used for the construction of full and partial dentures, which is a restorative rather than therapeutic function.
No
The device is described as "ENIGMA teeth" and "denture teeth," used for the construction of dentures. There is no indication that it is used to diagnose a medical condition or disease.
No
The device description clearly states "Schottlander ENIGMA denture teeth," indicating a physical product (denture teeth) and not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the construction of full and partial dentures using denture base resin. This is a mechanical and structural application within the mouth, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as "Schottlander ENIGMA denture teeth," which are physical components used in dental prosthetics.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. Denture teeth do not fit this description.
N/A
Intended Use / Indications for Use
ENIGMA 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.
Product codes
ELM
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
dental professional such as DDS or DMD
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three abstract human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 9 1999
Davis Schottlander & Davis, Ltd. C/O Mr. Clyde E. Ingersoll CEI Enterprises 54 Riverview Avenue Tonawanda, New York 14150-5260
Re : K984128 Trade Name: Enigma Denture Teeth Regulatory Class: II Product Code: ELM Dated: January 26, 1999 Received: January 26, 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 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 Requlations, Title 21, Parts 800 to 895. ಕ್ಷ 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 requlation may result in requlatory 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 - 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 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 ene regaration Chercrea) : 1255 andrig II 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
Timo Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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 ENIGMA denture teeth
INDICATIONS FOR USE
Device Name: Schottlander ENIGMA denture teeth
ENIGMA 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
Lccade.
Mohamed K Ladha Quality Assurance manager
Susan Raap
(Division Sign (Division) Division of Deata), tefection Control, and General Hospital Devices 510(k) Number
PRESCRIPTION DEVICE (Rx)