BRITESMILE MASKING CREAM

K040797 · Britesmile, Inc. · EIE · Apr 2, 2004 · Dental

Device Facts

• Record ID: K040797
• Device Name: BRITESMILE MASKING CREAM
• Applicant: Britesmile, Inc.
• Product Code: EIE · Dental
• Decision Date: Apr 2, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.6300
• Device Class: Class 1

Intended Use

The BriteSmile Masking Cream is intended to be used as an accessory to the BriteSmile Barrier Matcrial to protect soft tissue during teeth-whitening procedures.

Device Story

BriteSmile Masking Cream is a white topical cream (pH 6.5-7.0) used as an accessory to BriteSmile Barrier Material during teeth-whitening procedures. Applied to lips and mucosal areas distant from teeth; device acts as a thermal barrier to reduce heat transmission from the BriteSmile whitening lamp to soft tissues. Used in dental clinical settings by dental professionals to maintain patient comfort during bleaching. No electronic or mechanical components; functions via physical barrier properties.

Clinical Evidence

Bench testing only. Testing included biocompatibility, functionality, shelf life, and antimicrobial testing to validate safety and performance.

Technological Characteristics

White cream; pH 6.5-7.0. Functions as a physical thermal barrier. No energy source, software, or electronic components. Non-sterile, topical application.

Indications for Use

Indicated for protection of soft tissues (lips and mucosal areas) during teeth-whitening procedures to prevent exposure to heat from the BriteSmile activation lamp.

Regulatory Classification

Identification

A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in the center intended to isolate a tooth from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting a tooth through a hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. This classification does not include devices intended for use in preventing transmission of sexually transmitted diseases through oral sex; those devices are classified as condoms in § 884.5300 of this chapter.

Predicate Devices

• BriteSmile Barrier Material (K010935)

Submission Summary (Full Text)

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K040797

APR - 2 2004

# 510(k) Summary for BriteSmile Masking Cream

#### 1. SPONSOR

BriteSmile, Inc. 490 Wiget Lane Walnut Creek, CA 94598

Contact Person: Steven Miller Telephone: [phone]

Date Prepared: March 26, 2004

## 2. DEVICE NAME

Proprietary Name: BriteSmile Masking Cream Common/Usual Name: Gingival isolation material Classification Name: Rubber Dam

### 3. PREDICATE DEVICE

BriteSmile Barrier Material, K010935

# 4. INTENDED USE

The BriteSmile Masking Cream is intended to be used as an accessory to the BriteSmile Barrier Matcrial to protect soft tissue during teeth-whitening procedures.

### ડ. DEVICE DESCRIPTION

The BriteSmile Masking Cream protects the lips and mucosal areas farther away from the teeth that will not come into contact with the teeth whitening gel but which may be exposed to heat from the BriteSmile lamp used to activate the bleaching gel during the teeth whitening procedure. The BriteSmile Masking Cream is a white cream with a pH of 6.5 to 7.0.

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#### ર્દ્ર -BASIS FOR SUBSTANTIAL EQUIVALENCE

The BriteSmile Masking Cream is intended to be used with and has the same intended use as the BriteSmile Barrier Material. The Barrier Material protects the gingival areas adjacent to the teeth from the bleaching agent, a neutral pH, 15% hydrogen peroxide gel, and the masking cream reduces the transmission of heat gencrated by the BriteSmile Whitening lamp through to the soft tissue, thus maintaining patient comfort during the whitening procedure. Testing completed in conformance with established design control procedures to validate the safety and performance of the Masking Cream included biocompatibility, functionality, shelf life, and antimicrobial testing.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 2 2004

BriteSmile, Incorporated C/O Ms. Sheila Hemeon-Heyer, JD, RAC Director of Regulatory Services Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K040797

Trade/Device Name: BriteSmile Masking Cream Regulation Number: 21 CFR 872.6300 Regulation Name: Rubber Dam and Accessories Regulatory Class: I Product Codes: EIE and EEG Dated: March 26, 2004 Received: March 29, 2004

Dear Ms. Hemeon-Heyer:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave re revea your December in the device is substantially equivalent (for the indications for relected in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the encreated of the Mcdical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic nuve been toolabilited in an and 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 may of subjoct to been as 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. Sheila Hemeon-Heyer, JD, RAC

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) I mis lower will and a your finding of substantial equivalence of your device to a legally premaince nodicate 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 rryou decire 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" (21CFR please note in regarantin. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Susan Runnir

E. Chiu S. Lin, PhD 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):

K040-997

Device Name: BriteSmile Masking Cream

Indications for Use:

The BriteSmile Masking Cream is intended to be used as an accessory to the BriteSmile Barrier Material to protect soft tissues during teeth-whitening procedures.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Fvaluation (ODE)

Swaluny

Division Sign-Off Division of Anesthesiology, General Hospital. Intection Control. Dental D

510(k) Number: *K040797*