PERIOPATCH

K103054 · Izun Pharmaceuticals Corporation · OLR · Feb 7, 2011 · SU

Device Facts

• Record ID: K103054
• Device Name: PERIOPATCH
• Applicant: Izun Pharmaceuticals Corporation
• Product Code: OLR · SU
• Decision Date: Feb 7, 2011
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

PerioPatch is intended for the management of all types of oral wounds, injuries and ulcerations of the gingiva and oral mucosa, including stomatitis, minor chaffins and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lesions associated with oral surgery. PerioPatch operates to relieve pain by adharing to and protecting affected tissues from further irritation, thereby allowing healing.

Device Story

PerioPatch is a topical oral patch designed to manage oral wounds and ulcerations. It functions as a physical barrier that adheres to the gingiva or oral mucosa, protecting affected tissues from mechanical irritation and external stimuli. By shielding the wound site, the patch facilitates natural healing and provides pain relief. It is intended for use in clinical or home settings to treat conditions such as stomatitis, traumatic ulcers, and post-surgical lesions. The device is applied directly to the affected area by the patient or clinician.

Technological Characteristics

The device is an adhesive oral patch designed for topical application to mucosal tissues. It functions as a protective physical barrier. No specific materials, energy sources, or software components are described.

Indications for Use

Indicated for management of oral wounds, injuries, and ulcerations of gingiva and oral mucosa, including stomatitis, minor chaffings, traumatic ulcers, abrasions from braces/dentures, and oral surgery lesions in patients requiring protection of affected tissues to facilitate healing.

Regulatory Classification

Identification

Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.

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

Izun Pharmaceuticals Corporation C/O Mr. Irving Wiesen Law Offices of Irving L. Wiesen 420 Lexington Avenue New York, New York 10170

Re: K103054

Trade/Device Name: Periopatch Regulatory Class: Unclassified Product Code: MGO Dated: January 26, 2011 Received: January 28, 2011

FEB - 7 201

Dear Mr. Wiesen:

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. Wiesen

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/ucml 15809.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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

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

## Enclosure

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K103054

## Section 6: Statement of Indications for Use

510K number (if known):

Device Name: PerioPatch

Indications for Use:

PerioPatch is intended for the management of all types of oral wounds, injuries and ulcerations of the gingiva and oral mucosa, including stomatitis, minor chaffins and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lesions associated with oral surgery. PerioPatch operates to relieve pain by adharing to and protecting affected tissues from further irritation, thereby allowing healing.

Prescription Use X

Non-Prescription Use _________________________________________________________________________________________________________________________________________________________

Susan Burns
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K103054