ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES

K061199 · Braun GmbH · JEQ · May 31, 2006 · Dental

Device Facts

• Record ID: K061199
• Device Name: ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES
• Applicant: Braun GmbH
• Product Code: JEQ · Dental
• Decision Date: May 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6865
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

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

Device Story

Rechargeable electric toothbrush; consists of charging unit and rechargeable power unit. Uses oscillating/rotating technology; small round brush head with flagged bristles and power tips for interdental penetration. Oscillation frequency 63-73 Hz; vibration frequency 340 Hz (3800 strokes/min); oscillation angle 42°-60°. Inductively charged; thermoplastic enclosure; anti-slip handle. Used by patients in home setting for daily oral hygiene. Mechanical action facilitates plaque removal and gingivitis management. Wear indicator function included on bristles.

Clinical Evidence

Multiple controlled clinical studies evaluated safety, plaque removal, gingivitis, and bleeding. Results demonstrate effectiveness in treating and preventing gingivitis. Bench testing confirmed product integrity and compliance with UL 1431 standards.

Technological Characteristics

Oscillating/rotating powered toothbrush; Polyamid (PA6.12) bristles; thermoplastic enclosure; inductive charging; 100-120 V, 50-60 Hz supply. Complies with UL 1431. Features wear indicator colorant (FD&C blue No.2).

Indications for Use

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

Regulatory Classification

Identification

A powered toothbrush is an AC-powered or battery-powered device that consists of a handle containing a motor that provides mechanical movement to a brush intended to be applied to the teeth. The device is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.

Predicate Devices

• Sonicare® Advance Toothbrush (K040416)
• Oral-B® ProfessionalCare™Series/Oral-B® AdvancePower™Series

Submission Summary (Full Text)

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#### 510(k) SUMMARY

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Applicant:

Application Correspondent:

Braun GmbH Frankfurter Strasse 145 61476 Kronberg Germany

MAY 3 1 2006

Amanda Heffernan Manager, Requlatory Affairs Clinical Research & Dental affairs The Gillette Company 800 Boylston Street Prudential Tower Building. Floor 46 Boston, MA 02199-8004

Telephone: [phone] Fax: [phone] Email: amanda [e-mail]

Oral-B® AdvancePower™Series powered toothbrush

Oral-B® ProfessionalCare™ Series/

| Date summary prepared: | November 3, 2005 |
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Proprietary name of device:

Generic /classification name: Toothbrush, Powered

Product code (classification): JEQ (Class 1, 21 C.F.R. 872.6865)

#### Legally Marketed Predicate Devices:

- Sonicare® Advance Toothbrush (K040416) . Philips Oral Healthcare, Inc.
- . Oral-B® ProfessionalCare™Series/Oral-B® AdvancePower™Series Braun GmbH

## Device Description and Technological Characteristics:

Oral-B® ProfessionalCare/Oral-B® AdvancePower is a rechargeable electric toothbrush comprised of a charging unit and a rechargeable power unit. The rechargeable power unit is inductively charged and therefore electrically safe in accordance with the Second Edition of the standard for Personal Hygiene and Health Care appliances, UL 1431. The Oral-B® ProfessionalCare/Oral-B® AdvancePower electric toothbrush has an oscillating/rotating technology, a small round brush head that aids tooth-to-tooth cleaning. The brush head is designed to facilitate deeper penetration of interdental areas. The action of the brush head has an oscillation range frequency between 63 to 73 Hz with a vibration frequency of 340 Hz (3800 strokes per minute) and an oscillating range angle of 42° to 60° depending on the toothbrush model.

The brush head design is a small circular brush head and features an arrangement of flagged bristles and power tips. The power tips have tufts of longer bristles on either side of the brush head in the outer ring. These power tips have a wear indicator function and are colored with the FDA approved colorant FD&C blue No.2.

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### 510(k) SUMMARY Cont'd

The flagged bristle tufts have tetralocular filaments and are designed to increase the brushing action on tooth surfaces. The bristle material is Polyamid or PA6.12. The toothbrush features a round handle with anti-slip characteristics for better control in wet conditions and offers a variable range of speeds to best meet individual needs.

While power toothbrushes are 510(k) exempt device, we believe the expanded indication for use of treating and preventing gingivitis may exceed the limitation for 510(k) exemption. The expanded indications for use (i.e., treating and preventing gingivitis) are the only changes from the currently marketed devices Oral-B® ProfessionalCare ™Series/Oral-B® AdvancePower™Series. There are no changes to the design, materials or manufacturing process of these devices.

#### Indications for Use:

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

#### Testing:

Oral-B® ProfessionalCare ™ Series/Oral-B® AdvancePower™ Series powered toothbrushes have been tested in numerous controlled clinical studies. These trials evaluated oral soft and hard tissue for safety, plaque, gingivitis and bleeding. Collectively, these studies demonstrate that the Oral-B® ProfessionalCare™Series/ Oral-B® AdvancePower™Series powered toothbrush is effective at treating and preventing gingivitis.

Quality assurance testing on the Oral-B® ProfessionalCare ™Series/Oral-B® AdvancePower™Series electric toothbrush has been conducted to ensure the integrity of products.

Oral-B® Professional Care™ Series/Oral-B® AdvancePower™ Series products are rechargeable battery operated toothbrushes. The toothbrush handles are inductively charged so there is no electrical connection between the charger and handle. All electrical components are housed within thermoplastic enclosures and the product is provided with a Listed 1flexible supply cord terminating in a parallel blade attachment plug for connection to a nominal 100-120 V, 50-60 Hz supply source.

Oral-B® Professional Care™ Series/Oral-B® AdvancePower™ Series products are evaluated and comply with the applicable requirements to bear the Underwriters Laboratories Inc. Mark (UL 1431).

#### Conclusions:

The results from these tests support the safety and effectiveness of Oral-B® ProfessionalCare™ Series/Oral-B® AdvancePower™ Series power toothbrush and its substantial equivalence to the predicate device without raising new safety or effectiveness issues.

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## 510(k) SUMMARY Cont'd

## Bibliography

- 1. Cronin M, Dembling W, Warren P, King D.; A 3-month clinical investigation comparing the safety and efficacy of a novel electric toothbrush [Braun Oral-B 3D Plaque Remover] with a manual toothbrush. Am J Dent 1998; 11: (Spec Iss):S17-S21.
- 2. Haffajee A, Thompson M, Torresyap G, Guerrero D and Socransky S.; Efficacy of manual and powered toothbrush (1). Effect on clinical parameters. J Clin Periodontol 2001: 28: 937-946
- 3. Warren P, Cugini M.A., Marks P, King D.; Safety, efficacy and acceptability of a new power toothbrush: A 3-month comparative clinical investigation. Am J Dent 2001; 14: 3-7
- Rosema N.A., Timmerman M.F., Piscaer M., Strate J., Warren P.R., Van der Belden U., Van del বা Weijden G.A.; An oscillating/pulsating electric toothbrush versus a high-frequency electric toothbrush in the treatment of gingivitis.
- 5. Van der Weijden G.A., Timmerman M.K., Piscaer M., ljzerman Y., Warre P.R., Van der Velden U.; A comparison of the efficacy of a novel electric toothbrush and a manual toothbrush in the treatment of gingivitis. Am J Dent 1998; 11: (Spec Iss):S23-S28.
- 6. Van der Weijden G.A., Timmerman M.K., Piscaer M., ljzerman Y., Warre P.R., Van der Velden U.; A clinical comparison of three powered toothbrushes. J Clin Periodontol 2002; 29: 1042-1047.
- 7 . Isaacs R.L., Beiswanger B.B., Rosenfield S.T., Crawford J.L., Mau M.S., Eckert G.J., Warren P.R.; A crossover clinical investigation of the safety and efficacy of a new oscillating/rotating electric toothbrush and a high frequency electric toothbrush. Am J Dent 1998; 11: No.1: 7-12
- 8. Conforti N.J. , Chaves E.S., Leibman J.P., Warren P.R., Cugini M.A.; A comparative 3month clinical investigation of the safety and efficacy of a battery-operated and a rechargeable oscillating-rotating power toothbrush. Am J Dent 2001; 14: 59-62.

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Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized lines representing its wings.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 3 1 2006

Braun GmbH C/O Ms. Amanda Heffernan Manager, Regulatory Affairs The Gillette Company 800 Boylston Street Prudential Tower Building FL 46 Boston, Massachusetts 02199-8004

Re: K061199

Trade/Device Name: Oral-B® Professional Care™ Series/Oral-B® AdvancePower™ Series Regulation Number: 872.6865 Regulation Name: Powered Toothbrush Regulatory Class: I Product Code: JEQ Dated: March 20, 2006 Received: March 28, 2006

Dear Ms. Heffernan:

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 - Ms. Heffernan

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 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,

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): ____________________________________________________________________________________________________________________________________________________

Device Name: Oral-B® Professional Care™ Series/Oral-B® AdvancePower™ Series

Indications for Use: To promote good oral hygiene including plaque removal and treating and preventing gingivitis.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runge

Anot Anasthesiology, General Hospital, .Jn Control, Dental Devices

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