(79 days)
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.
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.
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.
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.
Here's the analysis of the provided text regarding acceptance criteria and study information:
This document does not contain information about acceptance criteria or a study that proves a device meets such criteria.
The provided text is a 510(k) summary for two denture cleanser products: "Cleanse.Freshen.Go. Aligner Cleansing Towelette" and "Cleanse.Freshen.Go. Dental Appliance Cleanser."
It primarily focuses on:
- Device Identification: Trade names, common names, classification, and predicate devices.
- Intended Use: Cleaning oral debris and killing odor-causing bacteria on removable dental appliances.
- Device Description: Physical characteristics (towelette vs. spray, packaging, ready-to-use nature).
- FDA Communication: A letter from the FDA to the applicant (Oral Health Technologies, LLC) stating that the devices are substantially equivalent to legally marketed predicate devices and can be marketed. This letter also outlines regulatory responsibilities.
- Indications for Use: Formal statements for both devices, reiterating their purpose.
Therefore, I cannot populate the table or answer the specific questions you've asked because the information is not present in the provided text.
The 510(k) process for this type of device (OTC Denture Cleanser, Class I) typically relies on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria and detailed performance studies like those seen for higher-risk medical devices or AI algorithms. The "study" mentioned here is implicitly the comparison to the predicate device, which the FDA has deemed sufficient for market clearance based on the information provided by the manufacturer.
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510(K) SUMMARY
Robert E. Tricca Contact: Vice President, Operations Oral Health Technologies, LLC Tel: (925) 215-5452
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
§ 872.3520 OTC denture cleanser.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.