RESO-PAC PERIODONTAL DRESSING

K050658 · Hager Worldwide, Inc. · EMA · May 27, 2005 · Dental

Device Facts

• Record ID: K050658
• Device Name: RESO-PAC PERIODONTAL DRESSING
• Applicant: Hager Worldwide, Inc.
• Product Code: EMA · Dental
• Decision Date: May 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

For use as a periodontal wound dressing to protect injured periodontal tissue by forming a barrier to avoid further irritation.

Device Story

Reso-Pac is a periodontal wound dressing used by dental professionals to protect injured periodontal tissue. It functions as a temporary physical barrier to prevent further irritation to the site. The device is applied topically to the affected area. It is intended for prescription use only.

Clinical Evidence

No clinical data provided; substantial equivalence is based on intended use and technological characteristics similar to legally marketed predicate devices.

Technological Characteristics

Periodontal wound dressing. Contains petrolatum/oil derivatives. Physical barrier mechanism. Professional dental use only.

Indications for Use

Indicated for use as a periodontal wound dressing to protect injured periodontal tissue by forming a barrier to avoid further irritation. Contraindicated in patients allergic to petrolatum products or oil derivatives. For professional dental use only; not for OTC use.

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

• PCA Periocare Periodontal Dressing (K881422)
• Barricaid (K864720)

Submission Summary (Full Text)

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## 510(k) Summary

Submitted by:

Daniel J. Manelli Manelli, Denison & Selter, P.L.L.C. 2000 M Street, NW (Suite 700) Washington, DC 20036

Telephone: [phone]

On behalf of Hager Worldwide, Inc. 510(k) Submission: Reso-Pac April 28, 2005

The product is a periodontal wound dressing. It is intended for use only by dental t no productioners; and will not be offered for OTC use. It contains materials that pose no health hazard when used according to directions. Reso Pac has received approval for marketing in the European Community. It is substantially equivalent to other manoling in the Larry - including PCA Periocare Periodontal Dressing (Pulpdent Corp. ponodental arobong of aboratories - K881422) and Barricaid (Dentsply International - K864720), which are intended to protect injured periodontal tissue by forming a temporary physical barrier to avoid further irritation.

Reso Pac should not be used with patients who are allergic to petrolatum products or oil derivatives.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three heads facing right, representing the department's focus on health, services, and people. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 7 2005

Hager Worldwide, Incorporated C/O Mr. Daniel J. Manelli Manelli Denison & Selter PLLC 2000 M. Street N.W. 7th Floor Washington, DC 20036-3307

Re: K050658

Trade/Device Name: Hager Reso Pac Periodontal Dressing Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: March 11, 2005 Received: March 15, 2005

Dear Mr. Manelli:

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 approvisions 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 (1 Nr.), I har be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device a may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Manelli

Please be advised that FDA's issuance of a substantial equivalence determination does not I least that FDA has made a determination that your device complies with other requirements mean that I Driver and regulations administered by other Federal agencies. or the rive of any 1 eder 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 and insure (s 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) I mis letet 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. 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:

Indications for use:

For use as a periodontal wound dressing to protect injured periodontal tissue by forming a barrier to avoid further irritation.

(Please Do Not Write Below This Line - Continue On Another Page if Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Renoe

(Civision Sign-Off) Civision of Anesthesiclogy, General Hospital, Intection Control, Dental Devices

510(k) Number: Ka5di6s7

Prescription Use √
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________