PERIOGENIX

K083516 · Oroscience, Inc. · EMA · Feb 20, 2009 · Dental

Device Facts

• Record ID: K083516
• Device Name: PERIOGENIX
• Applicant: Oroscience, Inc.
• Product Code: EMA · Dental
• Decision Date: Feb 20, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Periogenix is a periodontal wound dressing intended to protect injured periodontal tissue (gums) by forming a temporary physical barrier to avoid further irritation.

Device Story

Periogenix is a periodontal wound dressing system comprising a topical periodontal paste (TPP) and disposable dental trays. The TPP is dispensed into the tray, which is then seated over the affected area of the dental arch to provide a moist, temporary physical barrier against irritation. The device is used in a clinical or home setting; the TPP is applied three times daily for up to 10 days. After each application, the tray is removed and discarded. The system protects injured gum tissue, facilitating healing by preventing mechanical irritation. It is provided non-sterile for single use.

Clinical Evidence

Biocompatibility, animal, and clinical testing were performed to support the safety and effectiveness of the device. No specific numerical results or study parameters were provided in the summary.

Technological Characteristics

System consists of topical periodontal paste (TPP) and disposable dental trays. TPP is a premixed, biocompatible paste. Device is non-sterile, single-use. Application involves manual dispensing of paste into a tray and seating over the dental arch. No electronic components, energy sources, or software algorithms.

Indications for Use

Indicated for protection of injured periodontal tissue (gums) by forming a temporary physical barrier to avoid further irritation in patients requiring periodontal wound dressing.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Predicate Devices

• Coe-Pak Periodontal Dressing (K881422)
• Hager Reso-Pac Periodontal Dressing (K050658)

Submission Summary (Full Text)

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K0835/6

1 of 2

FEB 2009

510(k) Summary for OroScience, Inc Periogenix

### 1. SUBMITTER/510(K) HOLDER

OroScience, Inc. 2275 East Bayshore Road, Suite 105 Palo Alto, CA 94303 Telephone: [phone] Facsimile: 650-856-9601 E-mail: [e-mail]

Contact Person: Phil Houle Telephone: [phone]

Date Prepared: November 25, 2008

## 2. DEVICE NAME

Proprietary Name: Periogenix Common/Usual Name: Periodontal dressing Classification Name: Dental Cement

### 3. PREDICATE DEVICES

- Coe-Pak Periodontal Dressing, Coe Laboratories, Inc. (K881422) .
- Hager Reso-Pac Periodontal Dressing, Hager Worldwide, Inc, (K050658) .

# 4. DEVICE DESCRIPTION

Periogenix consists of thirty (30) disposable, single use dental trays and a canister of topical periodontal paste (TPP). The TPP is dispensed into the single use disposable dental tray, which together provide a moist temporary physical barrier that covers the site of application to avoid further irritation.

# 5. INTENDED USE

Periogenix is a periodontal wound dressing intended to protect injured periodontal tissue (gums) by forming a temporary physical barrier to avoid further irritation.

OroScience, Inc., Traditional 510(k) Periogenix

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K08 3516

## 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The basic design and application of Periogenix and the predicate devices are similar in that they all provide a temporary physical barrier for oral tissues after oral and periodontal surgery. The formulations of the proposed and predicate devices are different, although the difference in formulation does not affect safety or effectiveness since biocompatibility testing and a clinical evaluation have been performed to support the proposed Periogenix.

Both the proposed Periogenix and the Hager Reso-Pac Periodontal Dressings are similar in that they are neutral in smell and taste, ready-to-use, and provide for a temporary physical barrier. Periogenix TPP is dispensed into a dental tray and placed over the affected area of the dental arch three times daily for up to 10 days. After each treatment, the dental tray is removed and discarded. The Hager Reso-Pac is placed on an applicator and then applied to the affected area. The Reso-Pac stays in place for up to 30 hours and slowly dissolves.

The Coe-Pak Periodontal Dressing is slightly different than Periogenix and Reso-Pac in that the Coe-Pak Dressing is a two-part system consisting of a base and a catalyst that are mixed together chair-side by the dentist. After mixing, the paste is molded into the desired shape and packed over the surgical site on the dental arch after surgery. The paste hardens and the packing is left over the surgical site for up to 10 days until the patient returns to the dentist to have the hardened paste removed. Periogenix uses a premixed biocompatible TPP dispensed from a canister into a dental tray which, when placed over the surgical site of the dental arch, provides a temporary physical barrier. In some cases, the dentist may fabricate a custom dental tray specific to the patient's dental arch. The TPP is then dispensed into the custom dental tray and seated over the affected area of the dental arch three times daily for up to 10 days.

Periogenix and the predicate Coe-Pak and Reso-Pac Periodontal Dressings are all provided non-sterile to the user and are indicated for single use.

#### 7. PERFORMANCE TESTING

Biocompatibility, animal, and clinical testing have been performed and have shown that the proposed Periogenix is safe and effective for its intended use.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three stripes running through the body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.

# Public Health Service

FEB 2 0 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OroScience, Incorporated C/0 Ms. Mary McNamara-Cullinane, RAC Senior Regulatory Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K083516

> Trade/Device Name: Periogenix Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: February 12, 2009 Received: February 13, 2009

Dear Ms. McNamara-Cullinane:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 -- Ms. McNamara-Cullinane

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours

Suyite J. Michael Davis

Ginette Y. Michaud. M.D. Acting 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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510(k) Number (if known):

Device Name: Periogenix

Indications for Use:

Periogenix is a periodontal wound dressing intended to protect injured periodontal tissue (gums) by forming a temporary physical barrier to avoid further irritation.

Prescription Use X (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)

Susan Roreo

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

510(k) Number: R083516

OroScience, Inc., Traditional 510(k) Periogenix

November 25, 2008

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