MEDICAL INTERPOROUS

K051342 · Bonyf AG · EFT · Jun 2, 2006 · Dental

Device Facts

• Record ID: K051342
• Device Name: MEDICAL INTERPOROUS
• Applicant: Bonyf AG
• Product Code: EFT · Dental
• Decision Date: Jun 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3520
• Device Class: Class 1

Intended Use

Medical Interporous is a soaking treatment for the reduction of odor causing microorganisms on dentures and orthodontic retainers.

Device Story

Medical Interporous is a soaking treatment solution designed for cleaning dentures and orthodontic retainers. It functions by reducing odor-causing microorganisms on the surface of these dental appliances. The device is intended for use by patients at home to maintain appliance hygiene. By soaking the appliances in the solution, the device helps eliminate bacteria that contribute to unpleasant odors, thereby improving the user's oral hygiene and comfort.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Chemical soaking treatment for dental appliances; classified as an OTC Denture Cleanser (Product Code: NUX).

Indications for Use

Indicated for the reduction of odor-causing microorganisms on dentures and orthodontic retainers for patients requiring oral appliance hygiene.

Regulatory Classification

Identification

An OTC denture cleanser is a device that consists of material in the form of a powder, tablet, or paste that is intended to remove debris from removable prosthetic dental appliances, such as bridges or dentures. The dental appliance is removed from the patient's mouth when the appliance is cleaned.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The seal is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 2 2006

Ms. Donna Marie Hartnett Official Correspondent Bonyf AG 67 Main Street Silver Creek, New York 14136

Re: K051342

Trade/Device Name: MEDICAL INTERPOROUS Regulation Number: 872.3520 Regulation Name: OTC Denture Cleanser Regulatory Class: I Product Code: NUX Dated: May 10, 2006 Received: May 12, 2006

Dear Ms. Hartnett:

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. Hartnett

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 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,

Susa Vumpe

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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## Indications for Use

510(k) Number (if known): K051342

Device Name: MEDICAL INTERPOROUS

Indications for Use:

Medical Interporous is a soaking treatment for the reduction of odor causing microorganisms on dentures and orthodontic retainers."

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runno

f Anesthesiology, General Hospital,
Control, Dental Devices
K051342