CLEAN AND BOOST

K120620 · Apex Dental Materials, Inc. · KLE · May 31, 2012 · Dental

Device Facts

• Record ID: K120620
• Device Name: CLEAN AND BOOST
• Applicant: Apex Dental Materials, Inc.
• Product Code: KLE · Dental
• Decision Date: May 31, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Clean and Boost is an acidic, aqueous cleanser that has been designed to help remove contaminants from the surface of a tooth prior to bonding. These contaminants can be hand piece oil, tooth debris, or imaging powder (used to create digital impressions for CAD/CAM restorations).

Device Story

Clean and Boost is an acidic, aqueous cleanser used in dental clinics by dentists or dental professionals. It is applied to tooth surfaces to remove contaminants like hand piece oil, debris, or imaging powder before bonding procedures. By cleaning the surface, it prepares the tooth for optimal bonding, potentially improving the success of dental restorations. It is a manual application product.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Acidic, aqueous chemical cleanser. Formulated for surface preparation prior to dental bonding. No electronic, software, or mechanical components.

Indications for Use

Indicated for use as a tooth surface cleanser to remove contaminants such as hand piece oil, tooth debris, or imaging powder prior to dental bonding procedures. Prescription use only.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Mr. Chris Kulton Regulatory Consultant Apex Dental Materials, Inc. 330 Telser Road Lake Zurich, Illinois 60047

MAY 3 1 2012

Re: K120620

Trade/Device Name: Clean and Boost Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: May 21, 2012 Received: May 23, 2012

Dear Mr. Kulton:

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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## Page 2 - Mr. Kulton

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

for
Esther
Furniture

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use:

K120620

510(K) Number (if known):

Device name:

Clean and Boost

Clean and Boost is an acidic, aqueous cleanser that has been designed to help remove contaminants from the surface of a tooth prior to bonding. These contaminants can be hand piece oil, tooth debris, or imaging powder (used to create digital impressions for CAD/CAM restorations).

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

M

Prescription use X (Per 21 CFR 801.109 URSON Over- The- Counter Use

(Division Sign-Off)
Division of Anesthesiology, General Hospital(Optional Format 1-2-96)
Interaction Courted Davissa Infection Control, Dental Devices

510(k) Number: K120620

510K Submission for Clean and Boost Apex Dental Materials, 330 Telser Road Lake Zurich, IL 60047

CONFIDENTIAL

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