ZRP

K131049 · Apex Dental Materials, Inc. · KLE · Aug 27, 2013 · Dental

Device Facts

• Record ID: K131049
• Device Name: ZRP
• Applicant: Apex Dental Materials, Inc.
• Product Code: KLE · Dental
• Decision Date: Aug 27, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

ZrP is an ethanol based primer that improve the bond strengths of zirconia oxide restorations to restorative cements and bonding agents.

Device Story

ZrP is an ethanol-based dental primer; applied by dental professionals to zirconia oxide restorations; functions to enhance bond strength between restoration and restorative cements/bonding agents; used in clinical dental settings; improves clinical outcomes by ensuring secure adhesion of zirconia restorations.

Clinical Evidence

No clinical data provided; device is a chemical dental primer.

Technological Characteristics

Ethanol-based chemical primer; liquid form; intended for dental application.

Indications for Use

Indicated for use as a primer to improve bond strength of zirconia oxide restorations to restorative cements and bonding agents in dental patients.

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Submission Summary (Full Text)

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Public Health Service

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

## August 27, 2013

Apex Dental Materials, Incorporated Mr. Scott Lamerand 330 Telser Road LAKE ZURICH IL 60047

Re: K131049

Trade/Device Name: Zrp Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: June 3, 2013 Received: June 7. 2013

Dear Mr. Lamerand:

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 cnclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or 10 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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Page 2 - Mr. Lamerand

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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Kwame Ulmer M.S. Acting Division 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 (if known):

Device name: ZrP

Indications for use:

ZrP is an ethanol based primer that improve the bond strengths of zirconia oxide restorations to restorative cements and bonding agents.

Sheena A. Green -S2013.08.27 15:32:05 -04'00'

for M. Susan Runner, DDS, MA

(DivIsion Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: |< 13 \CV 4 9

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRL, Office of Device Evaluation (ODE)

Prescription use X (Per 21 CFR 801.109 OR

Over- The- Counter Use

(Optional Format 1-2-96)

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510K Submission for ZrP Apex Dental Materials, 330 Telser Road Lake Zurich, IL 60047

CONFIDENTIAL