(226 days)
Not Found
Not Found
No
The summary describes a material (milling disc) used in a CAD/CAM process for creating dentures. There is no mention of software, algorithms, or any computational processing that would typically involve AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is a material (milling disc) used to form new dentures, not a device that directly treats a medical condition or disease.
No
The device is described as a material used to form new dentures, indicating it is a prosthetic or restorative device, not one that identifies or analyzes a medical condition.
No
The device description clearly states it is a "CAD/CAM Milling Disc material," which is a physical material used in a milling process, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "form new dentures" for patients. This is a manufacturing process for a medical device (a denture), not a diagnostic test performed on a sample from the human body.
- Device Description: The device is a "CAD/CAM Milling Disc material." This is a material used in a manufacturing process.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample from the human body (blood, urine, tissue, etc.)
- Providing information about a disease, condition, or physiological state
- Using reagents or other diagnostic components
IVDs are used to perform tests on samples from the body to gain diagnostic information. This device is a material used to create a physical device that is placed in the body.
N/A
Intended Use / Indications for Use
Mycone Dental’s High-Impact Denture Acrylic CAD/CAM Milling Disc material, known as Keymill, is intended to be used to form new dentures. It is intended to be used only by professional dental practitioners who make dentures for patients.
Product codes
EBI
Device Description
Keymill High-Impact Denture Acrylic CAD/CAM Milling Disc
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional dental practitioners
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Mycone Dental Supply Company, Inc. (aka Keystone Industries) Priscilla Herpai Regulatory Team Lead 480 S Democrat Road Gibbstown, New Jersey 08027
April 27, 2018
Re: K172764
Trade/Device Name: Keymill Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: February 23, 2018 Received: February 26, 2018
Dear Priscilla Herpai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/4 description: The image shows the name "Mary S. Runner -S" in a clear, sans-serif font. The text is horizontally aligned and appears to be part of a document or label. The background is plain, ensuring the text is easily readable.
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
ATTACHMENT 2
510(k) Number (if known: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Device Name: Keymill High-Impact Denture Acrylic CAD/CAM Milling Disc
Indications For Use:
Mycone Dental's High-Impact Denture Acrylic CAD/CAM Milling Disc material, known as Keymill, is intended to be used to form new dentures. It is intended to be used only by professional dental practitioners who make dentures for patients.
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)