PRG BARRIER COAT

K122908 · Shofu Dental Corporation · LBH · Apr 26, 2013 · Dental

Device Facts

• Record ID: K122908
• Device Name: PRG BARRIER COAT
• Applicant: Shofu Dental Corporation
• Product Code: LBH · Dental
• Decision Date: Apr 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PRG BARRIER COAT, is a light-cured two-component mixing type, tooth sufface coating material as well as desensitizer to relieve dentin hypersensitivity.

Device Story

PRG BARRIER COAT is a light-cured, two-component dental material; applied to tooth surfaces by dental professionals; functions as a coating and desensitizer to treat dentin hypersensitivity; provides a protective barrier on the tooth surface; clinical benefit includes relief from sensitivity symptoms.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-cured, two-component mixing system; dental surface coating and desensitizing agent; class II device (21 CFR 872.3260, product code LBH).

Indications for Use

Indicated for use as a tooth surface coating material and desensitizer to relieve dentin hypersensitivity in patients requiring dental treatment.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 26, 2013

Mr. David-P .- Morais -Operations Manager and Official Correspondent Shofu Dental Corporation 1225 Stone Drive SAN MARCOS CA 92078

Re: K122908

Trade/Device Name: PRG BARRIER COAT Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: April 10, 2013 Received: April 11, 2013

Dear Mr. Morais:

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. Morais

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/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 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 vours.

Digitally signed by Mary S. Runner -S
ON: C=US, OU.S. Government,
Ou HHS, ou FDA, ou People,
Susan Runner, DOSMA Man Sumner
DU
0.9.2342.19200300.100.1.1-130008795
0
Date: 2013.04.26 12:39:29-04'00'

Anthony D. Watson, B.S., M.S., M.B.A. 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): K122908

Device Name: PRG BARRIER COAT

_Indications_For_Use: --------

PRG BARRIER COAT, is a light-cured two-component mixing type, tooth sufface coating material as well as desensitizer to relieve dentin hypersensitivity.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by Mary S. Runner -S
DN: c=US, o=U.S. Government, ou=HHS,
Susan Runner, DDS,MA ou=FDA, ou=People, cn=Mary S. Runner -
5,0.9.2342.19200300.100.1.1=1300087950
Date: 2013.04.26 14:42:54 -04′00′ IX

Shofu Dental Corporation PRG BARRIER COAT 510(k) Premarket Notification

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

510(k) Number:_K(229)