ORAL-B SUB-BRAND MANUAL TOOTHBRUSH

K073224 · Procter & Gamble · EFW · Feb 6, 2008 · Dental

Device Facts

• Record ID: K073224
• Device Name: ORAL-B SUB-BRAND MANUAL TOOTHBRUSH
• Applicant: Procter & Gamble
• Product Code: EFW · Dental
• Decision Date: Feb 6, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6855
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

To promote good oral hygiene including plaque removal and treating and preventing gingivitis.

Device Story

Manual toothbrush consisting of shaft with synthetic bristles; bristle patterns designed for mechanical plaque removal. Select tufts feature wear indicators colored with FD&C Blue No. 2. Used by patients in home setting for daily oral hygiene. Device functions via physical/mechanical action to remove plaque, thereby treating and preventing gingivitis. No electronic components or software.

Clinical Evidence

Multiple controlled clinical studies evaluated plaque removal efficacy and gingival health improvement. Results demonstrate that the mechanical action of the manual toothbrush is effective at treating and preventing gingivitis. Safety of the device on hard and soft oral tissues was also assessed.

Technological Characteristics

Manual toothbrush; shaft with synthetic bristles. Wear indicator bristles utilize FD&C Blue No. 2 colorant. Mechanical operation; no energy source. No software or connectivity.

Indications for Use

Indicated for individuals seeking to promote oral hygiene, remove plaque, and treat or prevent gingivitis.

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.

Predicate Devices

• Toothbrush, Manual EFW (21 CFR 872.6855)
• Toothbrush, Power JEQ (K061351)

Submission Summary (Full Text)

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| 510(k) Summary | |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Procter & Gamble<br>8700 Mason-Montgomery Road<br>Mason, OH 45202 |
| Applicant Correspondent: | Michael A. Kaminski, Ph.D.<br>Senior Scientist, Regulatory Affairs Manager<br>Procter & Gamble<br>8700 Mason-Montgomery Road<br>Mason, OH 45202<br><br>FEB - 6 2008 |
| | Telephone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Summary Prepared: | October 12, 2007 |
| Proprietary Name of Device: | Oral-B® “sub-brand” manual toothbrush<br>(i.e. CrossAction, Advantage, Pulsar, Pro-Health) |
| Generic/Classification Name: | Toothbrush, Manual |
| Product Code (Classification): | EFW (Class I, 21CFR 872.6855) |
| Legally Marketed Predicate Devices: | Toothbrush, Manual EFW (21 CFR 872.6855)<br>Toothbrush, Power JEQ (21 CFR 872.6865) K061351 |

Device Description and Technical Characteristics: The Oral-B® toothbrush is a manual toothbrush comprised of a shaft with synthetic bristles at one end. The bristles are arranged in a pattern to achieve effective mechanical plaque removal. Some of the bristle tufts have a wear indicator function. These Indicator bristles are colored with FDA approved colorant, FD&C Blue No. 2.

While manual toothbrushes are exempt devices, we believe the expansion of the indication to include for use of treating and preventing gingivitis may exceed the limitations of the 510(k) exemption. The expansion of the indication (treating and preventing gingivitis) is the only change from the currently marketed exempt device. There are no changes to the material, design or manufacturing process.

Indication for Use: To promote good oral hygier e including plaque removal and treating and preventing gingivitis.

Testing: Oral-B® manual toothbrushes have been tested in numerous controlled clinical studies. These trials evaluated the effectiveness of the manual brush at removing plaque and improving and maintaining gingival health. In addition on:l soft and hard tissue safety was assessed. Collectively, these studies demonstrate that Oral-B® manual toothbrushes are effective at treating and preventing gingivitis via the physical/mechanical removal of plaque.

The information provided supports the safety and effectiveness of Oral-BBC Conclusions: manual toothbrushes and their substantial equivalence to the predicate devices without raising any new safety and effectiveness issues.

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## Bibliography

- 1. M. J. Cronin, W. Dembling, N. Conforti, J. Liebman, M.A. Cugini, P. Warren: A single use and 3-month clinical inverstigation of the comparative efficacy of a battery-operated power toothbrush and a manual toothbrush. Special issue article Am J Dent 2001: 14:19B-24B
- N. Sharma, J. Qaqish, H. Galustians, D. King, M. Low, D. Jacobs, D. Weber: A 3-month r i comparative Investigation of the safety and c:Ticacy of a new toothbrush: Results from two independent clinical studies. Am J. Dent 2000, 13: Special Issue, 27A-32A
- A Six-Week clinical comparison of the Safety and Efficacy of Two manual Toothbrushes ﺘﻢ Hilltop Research. Inc. West palm Beach, Flerida, Final Report
- Nathoo S., Chaknis P., Petrone M., DeVizio W and Volpe AR: A Clinical Comparison of न the Gingivitis Reduction and Plaque-remov I Efficacy of a New Manual Toothbrush. Compendium 2004, 25(10) Suppl. 2:37-45
- Goyal C.R., Quaish J.G. and Galustians 1.: Efficacy and Safety of a New Power 5. Toothbrush in a population with Mild to Mederate Gingivitis. J Clin Dent 2007, 18:65-(59
- Yankell S.M., Emling R. and Percz B.: A Six-Month Clinical Evaluation of the Dentrust (). Toothbrush. J Clin Dent 1996, 7:106-109

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black against a white background. The seal is a symbol of the department's mission to protect the health of all Americans and provide essential human services.

Public Health Service

FEB - 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Michael A. Kaminski Senior Scientist, Regulatory Affairs Manager Procter & Gamble Company 8700 Mason-Montgomery Road Mason, Ohio 45040-9462

Re: K073224

Trade/Device Name: Oral-B® "sub-brand" manual toothbrush Regulation Number: 872.6855 Regulation Name: Manual Toothbrush Regulatory Class: I Product Code: EFW Dated: November 12, 2007 Received: November 15, 2007

Dear Dr. Kaminski:

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 – Dr. Kaminski

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 (OS) 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 proceed 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,

Chin-Lin, Ph.D.

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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## Indication for Use

K673224 510(k) Number (if known):

Device Name: Oral-B® "sub-brand" manual toothbrush

Indication For Use:

To promote good oral hygiene including plaque removal and treating and preventing gingivitis.

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _________________________________________________________________________________________________________________________________________________________ (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)

Susan Dunne

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K073224