CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER

K080631 · Oral Health Technologies, LLC · EFT · May 23, 2008 · Dental

Device Facts

• Record ID: K080631
• Device Name: CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER
• Applicant: Oral Health Technologies, LLC
• Product Code: EFT · Dental
• Decision Date: May 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3520
• Device Class: Class 1

Intended Use

Cleanse.Freshen.Go. Aligner Cleansing Towelette is intended for OTC use to clean oral debris from removable dental appliances after they have been removed from the mouth.

Device Story

Cleanse.Freshen.Go. Aligner Cleansing Towelette and Dental Appliance Cleanser are OTC products for cleaning removable dental appliances. The towelette version consists of a cleansing solution impregnated onto a towelette, supplied in hermetically sealed foil packages. The spray version is a liquid cleansing solution in a 2 oz. plastic pump spray bottle. Both products are ready-to-use, requiring no dilution or activation. They are designed for portability, allowing users to clean appliances in locations where traditional denture cleansers are impractical. The devices function by physically removing oral debris and killing odor-causing bacteria from the appliance surface. Users operate the devices manually to maintain appliance hygiene, potentially improving patient compliance with cleaning regimens.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The devices are OTC denture cleansers. The towelette is a pre-moistened wipe; the spray is a liquid solution in a plastic pump bottle. Both are ready-to-use, non-diluted formulations. No specific materials or software algorithms are described.

Indications for Use

Indicated for OTC use to remove oral debris and kill odor-causing bacteria associated with removable dental appliances.

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.

Predicate Devices

• Efferdent Anti-Bacterial Denture Cleanser

Submission Summary (Full Text)

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### 510(K) SUMMARY

Robert E. Tricca Contact: Vice President, Operations Oral Health Technologies, LLC Tel: [phone]

MAY 2 3 2008

Date Prepared: February 20, 2008

First Device Trade Name: Cleanse.Freshen.Go. Aligner Cleansing Towelette

Common Name: Denture Cleanser

Classification Name: OTC Denture Cleanser (21 CFR 872.3520, Product Code EFT)

Legally Marketed Predicate Device: Efferdent Anti-Bacterial Denture Cleanser (Manufactured by Warner Lambert, a division of Johnson & Johnson).

Intended Use of First Device: Cleanse.Freshen.Go. Aligner Cleansing Towelette is intended for OTC use to clean oral debris from removable dental appliances after they have been removed from the mouth.

First Device Description: Cleanse.Freshen.Go. Aligner Cleansing Towelette is a cleansing solution impregnated onto a towelette for cleaning oral debris from removable dental appliances. It does not require dilution or activation and the pre-moistened towelette is supplied in compact and portable foil laminated hermetically sealed packages. The ready-to-use product form enables faster and more frequent cleansing of removable dental appliances in locations otherwise found to be impractical with many denture cleanser alternatives.

Second Device Name : Cleanse. Freshen. Go. Dental Appliance Cleanser

Common Name: Denture Cleanser

Classification Name: OTC Denture Cleanser (21 CFR 872.3520, Product Code EFT)

Legally Marketed Predicate Device: Efferdent Anti-Bacterial Denture Cleanser

Second Device Description: Cleanse.Freshen. Go. Dental Appliance Cleanser is a spray liquid cleansing solution for cleaning oral debris from removable dental appliances. It does not require dilution or activation and is supplied in a 2 oz. plastic pump spray bottle that is compact and portable. The ready-to-use product form enables faster and more frequent cleansing of removable dental appliances in locations otherwise found to be impractical with many denture cleanser alternatives.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, clutching a staff with two snakes wrapped around it. The eagle and staff are black, and the background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2008

Mr. Robert E. Tricca Vice President Operations Oral Health Technologies, LLC 1062 Allegheny Drive Danville, California 94526

Re: K080631

Trade/Device Name: Cleanse.Freshen.Go. Aligner Cleansing Towelette Cleanse.Freshen.Go. Dental Appliance Cleanser Regulation Number: 21 CFR 872.3520 Regulation Name: OTC Denture Cleanser Regulatory Class: I Product Code: EFT Dated: May 19, 2008 Received: May 22, 2008

Dear Mr. Tricca:

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 - Mr. Tricca

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 procced 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, unper

z) 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): Not known

Device Name: Cleanse. Freshen. Go Aligner Cleansing Towelette

Indications for Use: Cleanse. Freshen. Go. Aligner Cleansing Towelette is indicated for OTC use to remove oral debris and kill odor causing bacteria associated with removable dental appliances.

Susan Runne

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

510(k) Number: K080631

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oral Health Technologies, LLC 510(k) Application

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# Indications for Use

### 510(k) Number (if known): Not known

Device Name: Cleanse. Freshen. Go. Dental Appliance Cleanser

Indications for Use: Cleanse.Freshen.Go. Dental Appliance Cleanser is indicated for OTC use to remove oral debris and kill odor causing bacteria associated with removable dental appliances.

Susan Runoe

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

510(k) Number: K080631

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oral Health Technologies, LLC 510(k) Application