SOUTH BEACH SMILE LIGHT WHITENING SYSTEM

K042153 · Dentovations, Inc. · EEG · Nov 8, 2004 · Dental

Device Facts

• Record ID: K042153
• Device Name: SOUTH BEACH SMILE LIGHT WHITENING SYSTEM
• Applicant: Dentovations, Inc.
• Product Code: EEG · Dental
• Decision Date: Nov 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6475
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The South Beach Smile Light Whitening System is intended to emit light in the 350 - 700 nanometer spectrums to provide a heat source for bleaching of teeth.

Device Story

Handheld, battery-operated light source device; emits blue visible light (350-700 nm) to activate photoactive substances in tooth whitening gel; generates 1-3°C heat against tooth surface. Used by consumers or dental professionals. Safety features include automatic 2-minute shut-off and light head design to prevent accidental eye exposure. Device acts as heat source to facilitate tooth bleaching; intended to provide safer, lower-intensity alternative to traditional whitening lights.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Handheld, battery-operated light source. Emits blue visible light (350-700 nm). Xenon light source. Generates 1-3°C heat. Includes automatic 2-minute shut-off timer and physical light-shielding head design.

Indications for Use

Indicated for use as a light source for bleaching teeth. Intended for consumer use or by dental professionals.

Regulatory Classification

Identification

A heat source for bleaching teeth is an AC-powered device that consists of a light or an electric heater intended to apply heat to a tooth after it is treated with a bleaching agent.

Predicate Devices

• BriteSmile
• Dental ZOOM Light

Submission Summary (Full Text)

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

K042153

NOV = 8 2004

# APPENDIX B

510(k) PREMARKET NOTIFICATION SUMMARY

(Per 21 CFR 807.92)

# DENTOVATIONS INC.

# SOUTH BEACH SMILE LIGHT WHITENING SYSTEM

### I. Applicant:

Dentovations Inc. 8 Faneuil Hall Marketplace, 3rd Floor Boston, MA 02109

Key Contact: M. Joyce Heinrich Texas Applied Biomedical Services, Inc. 12101 Cullen Blvd., # A Houston, Texas 77047 713 / 734-4433 telephone 713 / 734-5671 facsimile Email: [e-mail]

### II. Device Name

Proprietary Name: South Beach Smile Light Whitening System Common / Usual Name: Whitening Light System Heat source for bleaching teeth (21 CFR 872.6475) Classification Name: Product Code: EEB

### III. Predicate Device

The Dentovations Inc. South Beach Smile Light Whitening System is substantially equivalent to other tooth whitening lights currently in commercial distribution surrh as the BriteSmile and Dental ZOOM Light.

### IV. Intended Use of the Device

The South Beach Smile Light Whitening System is intended to emit light in the 350 - 700 nanometer spectrums to provide a heat source for bleaching of teeth.

### V. Description of the Device

The South Beach Smile Light Whitening System is intended for use by the consumer and sold either over the counter or by a dental professional as a yooth whitening system. The System consists of a handheld, battery operated light theat source) device, a whitening gel and preconditioning mouth wash.

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

The Whitening Light heat source is a hand held device that contains a biologically safe and effective level of blue visible light, which can penetrate the tooth and activate the photoactive substances within the tooth yielding a minimal amount of heat. The general wavelength is 350 -700 nm. The xenon light emits approximately 1 - 3 ° C heat agginst the tooth surface. To insure user safety when operating the light, the light has built in features that will eliminate any risk for the end user (1) light automatically shuts off after two minutes of use and (2) the light head acts a light automatouny shuts on and light from accidentally being exposed to the users eyes. The Whitening Light has been tested and proven to be safe for the consumer to use.

### Summary of the Technical Characteristics of the South Beach Smile Light VI. Whitening System as Related to the Referenced Predicate Devices.

The Dentovations Inc. South Beach Smile Light Whitening System and the aforementioned predicate devices are heat source for bleaching teeth as defined in 21 CFR 898.6475.

The South Beach Smile Light Whitening System is an economical tooth whitening light which in conjunction with the whitening gel and tooth whitening preconditioning mouth wash provides a heat source for bleaching teeth. The South Beach Smile Light Whitening System has similar intended use and technological characteristics to the predicate devices. The primary difference is the South Beach Smile Light Whitening System is proposed for use by the consumer and dental professions. Due to its low intensity light, the South Beach Smile Light Whitening System, is safer to user than other traditional heat sources for bleaching teeth.

### VII. Conclusions

Pursuant to the testing and comparison to the predicate devices, the Dentovations Inc. South Beach Smile Light Whitening System has the same intended use, with similar functional and performance characteristics. The Dentovations Inc. South Beach Smile Light Whitening System performs as intended and does not raise any new safety or efficacy issues.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 8 2004

Dentovations, Incorporated C/O Ms. M. Joyce Heinrich Regulatory Consultant Texas Applied Biomedical Services 12101 Cullen Boulevard, Suite A Houston, Texas 77047-2951

Re: K042153

Trade/Device Names: South Beach Smile Light Whitening System Regulation Number: 21 CFR 872.6475 Regulation Name: Heat Source for Bleaching Teeth Regulatory Class: I Product Code: EEG Dated: August 06, 2004 Received: August 13, 2004

Dear Ms. Heinrich:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determind the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce therefore and atthern is enactment date of the Medical Device Amendments. You may therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

In addition, we have determined that your device contains the following component whose regulatory status has not yet been determined: we someans the rollewing component whose Administration sent letters to manufacturers and/or distributors of tooth whitening preparations (such as the bleaching gel contained in your device) advising them that the agency considered the product drugs and "new drugs" as defined in the Federal Food, Drug, and Cosmetic Act (the act). Under the provisions of the act, a "new drug" may not be legally marketed in this country unless it is the subject of an approved New Drug Application (NDA). The NDA must commit un scientific data, including clinical trials, which establish that a product is safe and effective for its intended use.

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

# Page 2 - Ms. M. Joyce Heinrich

As a result of a court case brought by one of the manufacturers, the agency agreed to further evaluate the status of tooth whitener preparations to determine whether they should be regulated as "new drugs" or cosmetics. The agency has not yet completed that further evaluation. The status of urea peroxide, the whitening component of your device, is unresolved at this time.

Our substantially equivalent determination does not apply to the whitening component(s) of your device.

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.

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. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. If you desire specific advice for your device on the 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"(21 CFR Part 807.97). You may obtain other

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

Page 3 - Ms. M. Joyce Heinrich

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/dsma/dsmamain.html.

Sincerely yours,

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

{5}------------------------------------------------

# APPENDIX C

## Indications for Use

510(k) Number (if known): K042153

Device Name: South Beach Smile Light Whitening System

# Indications for Use:

The Dentovations South Beach Smile Light Whitening System is intended for use as a light source for bleaching teeth.

#### AND/OR Over the Counter Use: Prescription Use: X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODpE)

Susan Runser

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K042153