ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT

K141018 · Procter & Gamble Co. · JEQ · Sep 15, 2014 · Dental

Device Facts

• Record ID: K141018
• Device Name: ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT
• Applicant: Procter & Gamble Co.
• Product Code: JEQ · Dental
• Decision Date: Sep 15, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6865
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Oral-B® Test Drive Power Brush Trial Program Kit is intended for use as a power toothbrush to promote good oral hygiene, including the reduction of dental plaque and the treatment and prevention of gingivitis. The Oral-B® Test Drive Power Brush Trial Program Kit is indicated for use under the supervision of a dental professional as part of the Oral-B® Test Drive Power Brush Trial Program.

Device Story

Power toothbrush kit for dental office trial programs; includes rechargeable handle, charger, replacement brush heads, and plastic dental sheaths. Device used by patients under dental professional supervision to introduce power brushing. Handle is reusable across multiple users; kit includes instructions for cleaning and disinfection of handle between users. Sheaths prevent handle soiling. Output is mechanical brushing action for plaque removal and gingivitis management. Benefits include improved oral hygiene habits through professional-supervised trial.

Clinical Evidence

Bench testing only. Testing simulated normal and worst-case wear scenarios. Results confirmed handle integrity after repeated brush head fittings and seal durability. Disinfection testing verified that cleaning procedures effectively disinfect the handle without impacting physical characteristics or device performance.

Technological Characteristics

Rechargeable power toothbrush; includes plastic dental sheaths for hygiene. Features reusable handle designed for multi-user clinical trial environment. Biocompatible materials consistent with predicate. Connectivity: None. Energy source: Rechargeable battery. Sterilization: Not applicable (non-sterile).

Indications for Use

Indicated for patients requiring power toothbrushing for oral hygiene, plaque reduction, and gingivitis prevention/treatment; used under dental professional supervision in a trial program.

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

• Oral-B® Rechargeable Toothbrush (K061199)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized eagle with three human profiles incorporated into its design.

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

September 15, 2014

The Procter & Gamble Company Dr. Michael A. Kaminski Regulatory Affairs Manager 1 Procter & Gamble Plaza Cincinnati, Ohio 45202

Re: K141018

Trade/Device Name: Oral-B® Test Drive Power Brush Trial Program Kit Regulation Number: 21 CFR 872.6865 Regulation Name: Toothbrush, Powered Regulatory Class: I Product Code: JEO Dated: August 14, 2014 Received: August 15, 2014

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. 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.

{1}------------------------------------------------

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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## 4. Indications for Use Statement

### 510(k) Number (if known): To Be Assigned

Device Name: Oral-B® Test Drive Power Brush Trial Program Kit

#### Indications for Use:

The Oral-B® Test Drive Power Brush Trial Program Kit is intended for use as a power toothbrush to promote good oral hygiene, including the reduction of dental plaque and the treatment and prevention of gingivitis.

The Oral-B® Test Drive Power Brush Trial Program Kit is indicated for use under the supervision of a dental professional as part of the Oral-B® Test Drive Power Brush Trial Program.

Type of Use (Select one or both, as applicable)

Z Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Oral-B® Test Drive Power Brush Trial Program Kit 510(k)

Page 19 of 81 September 12, 2014

{3}------------------------------------------------

# 5. 510(k) Summary

510(k) Submission, Traditional; as required by (21CFR§807.92(c))

| 510(k) Owner: | The Procter & Gamble Company<br>1 Procter & Gamble Plaza<br>Cincinnati, Ohio 45202<br>Telephone: [phone] (Attention: Michael A. Kaminski)<br>Facsimile: [phone] (Attention: Michael A. Kaminski)<br>Establishment Registration Number: 9915005 | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Michael A. Kaminski, Ph.D.<br>Regulatory Affairs Manager<br>Global Product Stewardship<br>The Procter & Gamble Company<br>Telephone: [phone]<br>Email: [e-mail]<br>Facsimile: [phone] | |
| Date: | August 14, 2014 | |
| Trade Name: | Oral-B® Test Drive Power Brush Trial Program Kit | |
| Common name: | Power Toothbrush | |
| Classification Name: | Toothbrush, Powered | |
| Product Code: | JEQ | |

### Identification of a Legally Marketed Predicate Device

The Oral-B® Test Drive Power Brush Trial Program Kit ("program kit") is substantially equivalent to the Oral-B® Rechargeable Toothbrush marketed by Procter & Gamble, 510(k) Premarket Notification Number: K061199, FDA Product Code JEQ (Class I, 510(k) Exempt).

### General Description

The Oral-B® Test Drive Power Brush Trial Program is designed to introduce potential users to a power toothbrush as a means to promote good oral hygiene, including the reduction of dental plaque and the treatment and prevention of gingivitis. The program kit that is used in the trial program contains a power toothbrush consisting of a rechargeable handle, charger, replacement brush heads, and instructions for the proper use and care of the device. Additionally, the program kit contains plastic dental sheaths to prevent soiling of the multi-user handle and

{4}------------------------------------------------

instructions for cleaning and disinfection of the reusable handle. The program kit is indicated for use as an introductory trial to a power toothbrush under the supervision of a dental professional as part of the Oral-B® Test Drive Power Brush Trial Program.

### Intended Use/Indications for Use

The Oral-B® Test Drive Power Brush Trial Program Kit is intended for use as a power toothbrush to promote good oral hygiene, including the reduction of dental plaque and the treatment and prevention of gingivitis.

The Oral-B® Test Drive Power Brush Trial Program Kit is indicated for use under the supervision of a dental professional as part of the Oral-B® Test Drive Power Brush Trial Program.

### Comparison of Technological Characteristics

The Oral-B® Test Drive Power Brush Trial Program Kit is substantially equivalent to the Oral-B® Rechargeable Toothbrush (K061199) in intended use, design, dimensions, material biocompatibility and performance. The program kit differs from the Oral-B® Test Rechargeable Toothbrush device with regards to the cleaning and disinfections for the handle to permit multiple-users of the reusable handle. The program kit and the Oral-B® Rechargeable Toothbrush are both manufactured by Procter & Gamble Manufacturing GmbH (Marktheidenfeld, Germany) and distributed in the U.S.A. by Procter & Gamble, Co. (Cincinnati, Ohio).

### Brief Summary of Non-Clinical Tests and Results

Benchtop testing for the program kit was performed under conditions that simulated normal use and worst case scenario for wear. The performance testing demonstrated that the program kit handle can sustain multiple fittings of the brush head onto the reusable handle, and that the integrity of the seal remains intact with normal use. Benchtop testing also demonstrates that the cleaning and disinfection procedure results in satisfactory disinfection of the handle, and that the repeated exposure of the handle to the disinfectant had no effect on the physical characteristics or performance of the device.

### Basis of Substantial Equivalence

The Oral-B® Test Drive Power Brush Trial Program Kit is substantially equivalent to the Oral-B® Rechargeable Toothbrush in intended use, design, dimensions, materials, biocompatibility, and performance.

### Accessory Device

The Oral-B® Sheath, manufactured by TIDI Products, LLC, is provided to Procter & Gamble as a finished, packaged non-sterile device for inclusion in the program kit as an accessory device.