Keymill

K172764 · Mycone Dental Supply Company, Inc. (Aka Keystone Industries) · EBI · Apr 27, 2018 · Dental

Device Facts

• Record ID: K172764
• Device Name: Keymill
• Applicant: Mycone Dental Supply Company, Inc. (Aka Keystone Industries)
• Product Code: EBI · Dental
• Decision Date: Apr 27, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Keymill is a high-impact denture acrylic material supplied as a CAD/CAM milling disc. It is used by professional dental practitioners in a laboratory or clinical setting to fabricate new dentures. The practitioner uses CAD/CAM software to design the denture and a milling machine to carve the final prosthetic from the disc. The device serves as the raw material for the milling process, providing a high-impact acrylic structure for the final dental appliance. It benefits patients by enabling the creation of durable, custom-fitted prosthetic dentures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

High-impact denture acrylic resin in disc form for CAD/CAM milling. Class II device under 21 CFR 872.3760. Material properties are consistent with standard dental acrylics used for prosthetic fabrication.

Indications for Use

Indicated for use by professional dental practitioners to fabricate new dentures for patients requiring prosthetic dental appliances.

Regulatory Classification

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.

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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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

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## 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)