(85 days)
Not Found
No
The device description and performance studies focus on the physical properties and clinical efficacy of manual dental floss, with no mention of AI or ML.
No
The device is described as a dental floss, intended to remove plaque and food particles, and to treat and prevent gingivitis. While it has a therapeutic effect (treating/preventing gingivitis), it is a mechanical device for hygiene, not typically categorized as a medical therapeutic device in the sense of delivering active substances or complex medical treatments. Its therapeutic claim is based on physical removal to prevent disease, which is an adjunctive hygiene measure.
No
The description of the device (dental floss) and its intended use (plaque removal) indicates it is a tool for treatment and prevention, not diagnosis. It does not mention any ability to identify or characterize a disease state.
No
The device description clearly states it is a manual dental floss comprised of physical materials (polytetrafluoroethylene monofilament fiber, beeswax, gum arabic, water, flavor, etc.), indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to physically remove plaque and food particles from between teeth to reduce tooth decay and treat/prevent gingivitis. This is a mechanical action performed directly on the body (in the oral cavity).
- Device Description: The device is a manual dental floss made of physical materials. It does not involve any reagents, instruments, or systems used to examine specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like saliva, blood, etc.), detecting specific substances, or providing diagnostic information based on in vitro testing.
IVDs are devices used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This dental floss does not fit that definition.
N/A
Intended Use / Indications for Use
To remove plaque and food particles from between the teeth as part of a comprehensive dental treatment program to reduce tooth decay and to treat and prevent gingivitis.
Product codes
JES
Device Description
Crest Glide dental floss is a manual dental floss comprised of polytetrafluoroethylene monofilament fiber and a coating comprised of beeswax, gum arabic, water, flavor and other ingredients for color and cosmetic benefits. The floss was developed to improve ease of sliding between tight spaces to achieve effective plaque removal. Each of the materials that could come in contact with the user of this device is comprised of well-defined materials that are safe for use in the oral cavity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
between the teeth, oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Data from four clinical trials are provided that collectively show the addition of dental floss to tooth brushing is effective at treatment and prevention of gingivitis via the physical removal of plaque. The floss treatments in these studies were well tolerated with no safety issues.
Key Metrics
Not Found
Predicate Device(s)
Glide Comfort Plus Dental Floss, K073224
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6390 Dental floss.
(a)
Identification. Dental floss is a string-like device made of cotton or other fibers intended to remove plaque and food particles from between the teeth to reduce tooth decay. The fibers of the device may be coated with wax for easier use.(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 § 872.9.
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510(k) Number K091964 Summary
Applicant:
Applicant Correspondent:
Procter & Gamble 8700 Mason-Montgomery Road Mason, OH 45202
Victoria P. Schofield, Pharm.D. Regulatory Affairs Manager Procter & Gamble 8700 Mason-Montgomery Road Mason, OH 45040
Telephone: (513) 622-4851 Fax: (513) 622-1907 E-mail: schofield.vp@pg.com
Date Summary Prepared: September 04, 2009 Proprietary Name of Device: Crest Glide Dental Floss Generic/Classification Name: Dental floss Product Code (Classification): JES (Class I, 21CFR 872.6390) Legally Marketed Predicate Devices: Glide Comfort Plus Dental Floss
Oral-B Toothbrush (K073224)
Device Description and Technical Characteristics: Crest Glide dental floss is a manual dental floss comprised of polytetrafluoroethylene monofilament fiber and a coating comprised of beeswax, gum arabic, water, flavor and other ingredients for color and cosmetic benefits. The floss was developed to improve ease of sliding between tight spaces to achieve effective plaque removal. Each of the materials that could come in contact with the user of this device is comprised of well-defined materials that are safe for use in the oral cavity.
Indication for Use: To remove plaque and food particles from between the teeth as part of a comprehensive dental treatment program to reduce tooth decay and to treat and prevent gingivitis.
Supporting Information: Two substantially equivalent predicates have been provided, as well as clinical data to support the expanded indication.
- Currently marketed Glide Comfort Plus Dental Floss has the same design and . manufacturing process as the Crest Glide Dental Floss and is indicated for removal of plaque and prevention of tooth decay. Crest Glide Dental Floss uses the same mechanism of action (mechanical removal of plaque) to provide treatment and prevention of gingivitis. There are no new issues of safety or effectiveness.
- . Currently marketed Oral-B Toothbrush is indicated for treating and preventing gingivitis and uses the same mechanism of action as Crest Glide Dental Floss (mechanical removal of plaque) to achieve this benefit. There are no new issues of safety or effectiveness.
- Data from four clinical trials are provided that collectively show the addition of dental . floss to tooth brushing is effective at treatment and prevention of gingivitis via the
SEP 2 4 2009
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physical removal of plaque. The floss treatments in these studies were well tolerated with no safety issues.
Conclusions: Crest Glide Dental Floss is substantially equivalent to Glide Comfort Plus Dental Floss and Oral-B Toothbrush without raising any new safety and effectiveness issues. In addition, clinical data support the indication of treatment and prevention of gingivitis for dental floss above that provided by tooth brushing alone.
Bibliography
1
- Assessment of treatment responses to dental flossing in twins. Biesbrock A, Corby P, l. Bartizek R, Corby A, Coelho M, Costa S, Bretz WAG, Bretz WA. J of Periodont; August 2006,77(8):1386-91.
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- A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing. The University of Texas Health Science Center at San Antonio Dental School, USA. Study conducted in Guatemala. Final Study Report.
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- Comparative effectiveness of flossing and brushing in reducing interproximal bleeding. Graves RC, Disney JA, Stamm JW. J of Periodontol; May 1989;60(5): 243-247.
- Comparison of the use of different modes of mechanical oral hygiene in prevention 4. of plaque and gingivitis. Rosema NAM, Timmerman MF, Versteeg PA, van Palenstein Helderman WH, Van der Velden U, Van der Weijden GA. J of Periodontol; August 2008;79(8): 1386-1394.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SEP 2 4 2009
Procter & Gamble Company Ms. Victoria P. Schofield Regulatory Affairs Manager Oral Care 8700 Mason-Montgomery Road Mason, Ohio 45040
Re: K091964
Trade/Device Name: Crest Glide Dental Floss Regulation Number: 872.6390 Regulation Name: Dental Floss Regulatory Class: I Product Code: JES Dated: June 30, 2009 Received: July 1, 2009
Dear Ms. Schofield:
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 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. Schofield
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Nh for
Susan Runner, D.D.S., M.A. 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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Indication for Use
510(k) Number: K091964
Device Name: Crest Glide Dental Floss
Indication For Use:
To remove plaque and food particles from between the teeth as part of a comprehensive dental treatment program to reduce tooth decay and to treat and prevent gingivitis.
Prescription Use (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use _ X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Kein Mulley for NSR
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091964
Section 4
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