ClearMet

K152051 · Mycone Dental Supply Co., T/A Keystone Industries · EBI · Mar 22, 2016 · Dental

Device Facts

• Record ID: K152051
• Device Name: ClearMet
• Applicant: Mycone Dental Supply Co., T/A Keystone Industries
• Product Code: EBI · Dental
• Decision Date: Mar 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fabrication of removable dental prosthetic devices, such as full and partial dentures, occlusal splints and night guards.

Device Story

ClearMet is a dental resin material used for the fabrication of removable dental prosthetics, including full and partial dentures, occlusal splints, and night guards. It is intended for professional use by dental clinicians in a laboratory or clinical setting. The device functions as a restorative material to replace missing teeth or provide occlusal protection. It is processed by dental technicians or clinicians to form the final prosthetic shape. The output is a custom-fitted dental appliance that restores oral function, aesthetics, or provides therapeutic protection for the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Denture relining, repairing, or rebasing resin. Class II device. Regulated under 21 CFR 872.3760. Product code EBI.

Indications for Use

Indicated for the fabrication of removable dental prosthetic devices, including full and partial dentures, occlusal splints, and night guards in patients requiring such 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 22, 2016

Mycone Dental Supply Co., t/a Keystone Industries, Mizzy & Deepak Products Ms. Tracey Schwear Manager QA/RA 52 West King Street Myerstown, Pennsylvania 17067

Re: K152051

Trade/Device Name: ClearMet Regulation Number: 21 CFR 872.3760 Regulation Name: Denture relining, repairing, or rebasing resin Regulatory Class: II Product Code: EBI Dated: February 22, 2016 Received: February 23, 2016

Dear Ms. Schwear:

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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Image /page/1/Picture/8 description: The image shows the signature of Tina Kiang. The signature is written in black ink and is on a white background. The signature is illegible, but the name "Tina Kiang" is written above it.

for Erin I. Keith, M.S. 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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## Indications for Use

510(k) Number: __ K152051

Device Name: Clearmet

Indications For Use:

Fabrication of removable dental prosthetic devices, such as full and partial dentures, occlusal splints and night guards.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)