(171 days)
The Easy Brush with fluoride is intended to mechanically remove plaque and food particles from between teeth to reduce tooth decay. It is to be used with an in and out motion to clean between interdental space as it is done with floss, and other interdental cleaners such as tooth picks.
The Easy Brush with fluoride is an interdental brush designed to clean between teeth. It is composed of 4 parts (a handle, a wire, bristles, and a cap). The wire is twisted around the nylon filaments to create the brush, and then is molded onto a plastic handle. It is then coated with a solution containing flavor and sodium fluoride and then capped off.
This document describes DenTek Oral Care Inc.'s Easy Brush with fluoride. However, the provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a 510(k) summary for a medical device (an interdental brush with fluoride) and focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. It covers:
- Device Identification: Name, classification, predicate devices.
- Intended Use: Mechanically remove plaque and food particles, reduce tooth decay.
- Technological Characteristics: Components (handle, wire, bristles, cap), coating with flavor and sodium fluoride.
- Substantial Equivalence: Comparison to existing FDA-cleared devices (Oral-B Woodsticks with Fluoride and Johnson & Johnson Fluoride Dental Floss, Mint Waxed).
- Biocompatibility: Justified by reference to existing approved devices and safe levels of sodium fluoride in public water.
- FDA Clearance Letter: Formal letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide a table of acceptance criteria or details about a study to prove the device meets them because this information is not present in the provided text.
To answer your request, the input text would need to include sections detailing performance specifications, study design, results, and expert involvement.
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510(k) SUMMARY-Revised
DenTek Oral Care Inc.'s Easy Brush with fluoride (K130186)
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Linda Giles Date Prepared: January 24, 2013 Revision Date: June 12, 2013
Name of Device and Name/Address of Sponsor
Easy Brush with fluoride DenTek Oral Care, Inc. 307 Excellence Way Maryville, TN 37801 Phone: (865) 983-1300 Facsimile: (865) 983-2444
Common or Usual Name
Interdental brush
Classification Name
Manual toothbrush
Classification Product Code
EFW, Class I
Predicate Devices
Oral-B Woodsticks with Fluoride (K942633) and "Johnson & Johnson Fluoride Dental Floss, Mint Waxed" (K935440).
Purpose of the Traditional 510(k) notice.
The Easy Brush with fluoride is a modification to DenTek Oral Care Inc.'s Easy Brush. FDA device listing number B094614, on which a flavor and fluoride solution has been applied. Each brush contains approximately 0.15mg sodium fluoride in the flavor coating.
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Intended Use
The Easy Brush with fluoride is intended to mechanically remove plaque and food particles from between teeth to reduce tooth decay. It is to be used with an in and out motion to clean between interdental space as it is done with floss, and other interdental cleaners such as tooth picks.
Technological Characteristics
The Easy Brush with fluoride is an interdental brush designed to clean between teeth. It is composed of 4 parts (a handle, a wire, bristles, and a cap). The wire is twisted around the nylon filaments to create the brush, and then is molded onto a plastic handle. It is then coated with a solution containing flavor and sodium fluoride and then capped off.
Substantial Equivalence
The Easy Brush with fluoride is intended to mechanically remove plaque and food particles from between teeth to reduce tooth decay. As described in more detail in the Substantial Equivalence Chart-Revised, (page 4 of this submission), which lists the devices' similarities and differences, the Easy Brush with fluoride has the same intended use as "Oral-B Interdental Woodsticks with Fluoride" (K942633) and "Johnson & Johnson Fluoride Dental Floss, Mint Waxed" (K935440).
Biocompatibility
The biocompatibility of the device relies upon testing done on approved devices such as DENTSPLY 5% Sodium Fluoride Vamish K122331, which was reported to have no biocompatibility issues, and upon the predicate devices mentioned above which contain an amount of sodium fluoride that is substantially equivalent to the subject Easy Brush with fluoride. In addition, bottled drinking water and tap water are also approved to contain sodium fluoride in amounts proven to be safe and beneficial to the public as an anti-caries agent. Therefore, the Easy Brush with fluoride at a level of approximately 0.15 mg per brush is also biocompatible.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 15, 2013
DenTek Oral Care, Incorporated Ms. Linda Giles Regulatory Specialist 307 Excellence Way MARYVILLE TN 37801
Re: K130186
Trade/Device Name: Easy Brush with Fluoride Regulation Number: 21 CFR 872.6855 Regulation Name: Manual Toothbrush Regulatory Class: 1 Product Code: EFW Dated: June 12, 2013 Received: June 13, 2013
Dear Ms. Giles:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.
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. Giles
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Easy Brush with fluoride
Indications for Use:
The Easy Brush with fluoride is intended to mechanically remove plaque and food particles from between teeth to reduce tooth decay. It is to be used with an in and out motion to clean interdental spaces, as it is done with dental floss.
Prescription Use . (Per 21 C.F.R. 801.109) AND/OR
Over-The-Counter Use_X_ (Per 21 C.F.R. 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary S. Runner -S
| Susan Runner DDS MA |
| 2013.07.12 | |
|---|---|
| 14:13:46 -04'00' |
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K130186 |
|---|---|
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§ 872.6855 Manual toothbrush.
(a)
Identification. A manual toothbrush is a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.(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. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.