PCXX VARNISH

K113146 · Ross Healthcare, Inc. · LBH · Jan 23, 2012 · Dental

Device Facts

• Record ID: K113146
• Device Name: PCXX VARNISH
• Applicant: Ross Healthcare, Inc.
• Product Code: LBH · Dental
• Decision Date: Jan 23, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Treatment of hypersensitive teeth. Use on exposed dentin and root sensitivity. Under temporary restoratives and cements where post-operative sensitivity is of concern.

Device Story

PCXX Varnish is a 5% sodium fluoride varnish designed to reduce tooth sensitivity. It functions by forming a protective film when topically applied to enamel and dentin surfaces. The device consists of a rosin-based mixture in an ethanol solution, supplied in a single-unit dose package with an applicator brush. It is intended for professional use by dental clinicians in a clinical setting. By creating a physical barrier on the tooth surface, the varnish mitigates sensitivity, providing relief to patients experiencing dentin or root hypersensitivity and protecting against post-operative sensitivity under temporary restorations.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on the use of identical chemical components (rosin/colophony derivatives) and formulation (ethanol solution) as legally marketed predicate devices.

Technological Characteristics

5% Sodium Fluoride varnish; rosin (colophony) or rosin derivative (CAS# 65997-06-0) in ethanol solution; single-unit dose packaging with applicator brush; topical application; non-electronic; no software.

Indications for Use

Indicated for patients requiring treatment of hypersensitive teeth, including exposed dentin and root sensitivity, or under temporary restoratives and cements to address post-operative sensitivity.

Regulatory Classification

Identification

Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.

Special Controls

*Classification.* Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Predicate Devices

• Duraflor (K961893)
• Duraphat (K945794)
• Fluorilag (K030488)

Submission Summary (Full Text)

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# 113146

# Chapter 6 510(k) Summary

This summary of 510(k) Safety and Effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92

#### Submitter Information 1.

Ross Healthcare Inc. 1750 Grant Ave Blaine, WA, 98230

Subject: Abbreviated 510(k) PCXX Fluoride Varnish

Contact Person

Marc N. Ross Phone: [phone] Fax: Email: [e-mail]

Date Prepared: October 5, 2011-10-05

- 2. Device Name
PCXX Varnish Trade Name: Cavity Varnish Common Name: Classification Name: Cavity Varnish (21 CFR 872.3260)

#### 3. Predicated Devices

| Device | Company | K Number |
|-----------|--------------------|----------|
| Duraflor | Pharmascience, Inc | K961893 |
| Duraphat | Colgate | K945794 |
| Fluorilag | Pascal Co., Inc. | K030488 |

# 4.&5. Description and Intended Use

PCxx Varnish is 5% Sodium Fluoride Varnish that reduces tooth sensitivity by forming a film when topically applied to enamel and dentin surfaces.

The properties, intended use and composition are equivalent to the predicated devices and other current varnishes which are rosin based insoluble mixtures that form a film when applied to tooth surfaces.

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### Technological Characteristics 6.

PCxx Varnish used the same rosin (colophony) and rosin derivatives that are used PCXX Vanush ascu the same room (0010) - 100 persons include but are not limited to Duraflor, Duraphat and Fluorilaq.

The product comes in a single unit dose package containing the varnish and separate applicator brush.

## Performance and Comparison Data 7.

The sealant used in predicate devises is the same material used in the submitted I he sealant used in predicate devises to the rosin derivative of CAS# 65997-06-0
devices. The sealant used is a colophony, rosin or rosin derivative for this readuct devices. The sealant used is a colophority, room or randards established for this product
in an ethanol solution. There are no performance standards established to this produ in an ethanol solution. There are no perfections of essess thows it to be substantially equivalent, performance will be the same.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white.

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

JAN 2 3 2012

Mr. Marc N. Ross President Ross Healthcare, Inc. 1750 Grant Avenue Blaine, WA 98230

Re: K113146

Trade/Device Name: PCXX Varnish Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: January 6, 2012 Received: January 17, 2012

## Dear Mr. Ross:

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. Ross

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,

Wh for

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

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# Chapter 4.

Indications for Use

e (K113146)

510(k) Number :

Device Name:

PCXX Varnish Trade Name: Cavity Varnish Common Name: Classification Name: Cavity Varnish (21 CFR 872.3260)

Indications For Use:

- Treatment of hypersensitive teeth ●
- Use on exposed dentin and root sensitivity .
- Under temporary restoratives and cements where post-operative sensitivity is of . concern.

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

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

Susan Rumm
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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