CREST TOOTHBRUSH WITH MICROSHIELD

K973236 · Procter & Gamble Co. · EFW · Mar 11, 1998 · Dental

Device Facts

• Record ID: K973236
• Device Name: CREST TOOTHBRUSH WITH MICROSHIELD
• Applicant: Procter & Gamble Co.
• Product Code: EFW · Dental
• Decision Date: Mar 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6855
• Device Class: Class 1

Intended Use

The Crest Toothbrush with MicroShield is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay. The addition of the antimicrobial agent is to prevent the growth of bacteria on the toothbrush between brushings. The antimicrobial treatemnt is not intended to have any effect on the user.

Device Story

Manual toothbrush; shaft with synthetic bristles; removes plaque and food debris from teeth; reduces tooth decay; contains antimicrobial agent to prevent bacterial growth on brush between uses; intended for consumer use; antimicrobial treatment has no effect on user.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manual toothbrush; synthetic bristles; handle and bristle materials identical to existing Crest toothbrushes; contains antimicrobial agent (triclosan) to inhibit bacterial growth on the device.

Indications for Use

Indicated for removal of adherent plaque and food debris from teeth to prevent tooth decay and to prevent bacterial growth on the toothbrush between brushings for general population use.

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

• Crest Toothbrushes
• Butler G.U.M. Antibacterial Toothbrush (K950993)

Submission Summary (Full Text)

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Procter&Gamble

K973236

The Procter & Gamble Company Health Care Research Center 8700 Mason-Montgomery Road, Mason, Ohio 45040-9462

# MAR 11 1998

### Premarket Notification [510(k)] Summary

This summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR §807.92(c).

#### Submitter's Name. Address and Phone Number

The Procter & Gamble Company P.O. Box 599 Cincinnati. Ohio 45202 Phone: [phone] Fax: [phone] Contact person: Marlene B. Feder Preparation Date: 8/26/97

#### Name of the Device

Trade Name: Crest Toothbrush with MicroShield Common Name: Manual Toothbrush Classification Name: Manual Toothbrush (per 21 CFR §872.6855)

#### Predicate Devices

This premarket notification is claiming substantial equivalence to Crest Toothbrushes and the Butler G.U.M. Antibacterial Toothbrush (K950993).

#### Description of the Device

The Crest Toothbrush with MicroShield is a manual toothbrush consisting of a shaft with synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay. The toothbrush contains an antimicrobial agent to prevent the growth of bacteria on the brush between uses, maintaining the cleanliness of the brush.

#### Intended Use of the Device

The Crest Toothbrush with MicroShield is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay. The addition of the antimicrobial agent is to prevent the growth of bacteria on the toothbrush between brushings. The antimicrobial treatemnt is not intended to have any effect on the user.

#### Comparison of Technological Characteristics

The Crest Toothbrush with MicroShield is composed of handle and bristle materials identical to other Crest Toothbrushes. Like the Butler G.U.M. Antibacterial Toothbrush (K950993), the Crest Toothbrush with MicroShield contains an antimicrobial agent to prevent the growth of bacteria on the brush between uses. Both the Butler G.U.M. Antibacterial Toothbrush and the contain an antimicrobial ingredient. While the antimicrobial agents in the two brushes are different, the antimicrobial activity of the triclosan containing brush is expected to be, at a minimum, comparable to the antimicrobial activity of chlorhexidine/zinc oxide containing brush.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, facing right. The eagle is composed of three curved lines that suggest movement and flight. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR | | | |998

Ms. Marlene B. Feder Manager, Regulatory Affairs Proctor & Gamble Company 8700 Mason-Montqomery Road Mason, Ohio 45040-9462

Re : K973236 Crest Toothbrush with Microshield Trade Name: Requlatory Class: I Product Code: EFW Dated: December 19, 1997 December 22, 1997 Received:

Dear Ms. Feder:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਸ substantially.equivalent_determination.assumes compliance with --the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Feder

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

Alildris

Timo Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## PROCTER & GAMBLE COMPANY 510(k) Notification

### Manual Antimicrobial Toothbrush

510(k) Number (if known):

Device Name: Crest Toothbrush with MicroShield

Indications for use:

To remove adherent plaque and food debris from the teeth to prevent tooth decay.

To prevent the growth of bacterial between brushings to maintain the cleanliness of the toothbrush.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) All H, Office of Device Evaluation (ODE) Over-the-Counter Use V ਉਕ (Per 21 CFR 801.109)