SILVER CARE ANITBACTERIAL TOOTHBRUSH

K102871 · Piave Spazzolificio S.P.A. · EFW · Oct 3, 2011 · Dental

Device Facts

• Record ID: K102871
• Device Name: SILVER CARE ANITBACTERIAL TOOTHBRUSH
• Applicant: Piave Spazzolificio S.P.A.
• Product Code: EFW · Dental
• Decision Date: Oct 3, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6855
• Device Class: Class 1

Intended Use

The Silver Care Antibacterial Toothbrush is intended for over-the-counter use as a toothbrush. The antibacterial agent maintains the cleanliness of the brush by preventing the growth of bacteria on and between the filaments after use. The Silver Care is effective against E. coll (ATCC 25922), Klebsiella pneumoniae (ATCC 13388), Streptococcus mutans (ATCC 35668), and Pseudomonas aeruginosa (ATCC 27853) at 24 hours of exposure under moist conditions.

Device Story

Manual toothbrush; incorporates antibacterial agent on filaments to inhibit bacterial growth between uses. Used by general public for oral hygiene. Device maintains cleanliness of brush head; effective against E. coli, K. pneumoniae, S. mutans, and P. aeruginosa after 24 hours in moist conditions.

Clinical Evidence

Bench testing only; efficacy demonstrated against E. coli, K. pneumoniae, S. mutans, and P. aeruginosa at 24 hours of exposure under moist conditions.

Technological Characteristics

Manual toothbrush; antibacterial agent integrated into filaments. No electronic components or software.

Indications for Use

Indicated for over-the-counter use as a manual toothbrush for general population.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Spazzolificio PIAVE S.p.A. % Ms. Keila Lacourt Consultant Ganesh Group 212 West 91st Street Apt 812 New York, New York 10024

OCT - 3 2011

Re: K102871

Trade/Device Name: Silver Care Antibacterial Toothbrush Regulation Number: 21 CFR 872.6855 Regulation Name: Manual Toothbrush Regulatory Class: I Product Code: EFW Dated: September 23. 2011 Received: September 26, 2011

Dear Ms. Lacourt:

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. Lacourt

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.

lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutlFDA/CentersOffices/CDRH/CDRHOffices/ ucm 1.5.809.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 hup://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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

h for

Anthony D. Watson, B.S., M.S., M.B.A. 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):

Device Name: Silver Care Antibacterial Toothbrush

ations For Use:

The Silver Care Antibacterial Toothbrush is intended for over-the-counter use as a toothbrush. The antibacterial agent maintains the cleanliness of the brush by preventing the growth of bacteria on and between the filaments after use. The Silver Care is effective against E. coll (ATCC 25922), Klebsiella pneumoniae (ATCC 13388), Streptococcus mutans (ATCC 35668), and Pseudomonas aeruginosa (ATCC 27853) at 24 hours of exposure under moist conditions.

| Prescription Use<br>(Part 21 CFR 001 Subpart D) | |
|-------------------------------------------------|---|
| AND/OR | |
| Over-The-Counter Use<br>(21 CFR 001 Subpart C) | X |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | <i>Susan Runer</i> |
|-----------------------------------------------------------------------------------|--------------------|
| | |
| Division of Anesthesiology, General Hospital<br>Infection Control, Dental Devices | |
| §10(k) Number: | K102871 |

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