(91 days)
The Dentovations South Beach Smile Light Whitening System is intended for use as a light source for bleaching teeth.
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. 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 provided text is a 510(k) Premarket Notification Summary for the "South Beach Smile Light Whitening System." It focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance data from a specific study with acceptance criteria.
Therefore, many of the requested categories for a study proving acceptance criteria cannot be extracted because such a study is not presented in the provided document. The document describes the device, its intended use, and compares its technical characteristics to predicate devices. It states that the device has been tested and proven to be safe for the consumer to use, but it does not detail the specific tests, acceptance criteria, or their results in a quantitative manner as requested.
Here's an attempt to answer based on the available information, with many points noted as "Not provided in the text":
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: | |
| Minimal heat generation | Emits approximately 1 - 3 °C heat against the tooth surface. |
| Automatic shut-off | Automatically shuts off after two minutes of use. |
| Light head shields eyes | Light head acts as a shield to prevent light from accidentally being exposed to the user's eyes. |
| Biologically safe light level | Contains a biologically safe and effective level of blue visible light. |
| Functional/Technological Characteristics: | |
| Light wavelength | Emits light in the 350 - 700 nanometer spectrums. General wavelength: 350 - 700 nm. |
| Intended Use | Intended to emit light in the 350 - 700 nanometer spectrums to provide a heat source for bleaching of teeth. Performs as intended. |
| Substantial equivalence to predicate device | Has the same intended use, with similar functional and performance characteristics to predicate devices (BriteSmile and Dental ZOOM Light). |
2. Sample size used for the test set and the data provenance
Not provided in the text. The document states "The Whitening Light has been tested and proven to be safe for the consumer to use," but no details on the sample size or provenance of this testing are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document describes device characteristics and safety features, not a diagnostic or classification task requiring expert ground truth for a test set.
4. Adjudication method for the test set
Not applicable, as no test set requiring ground truth adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a light source for tooth whitening, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not relevant to the described device, which is a physical light system. The closest equivalent is the device's inherent performance characteristics as described in point 1.
7. The type of ground truth used
Not applicable. The "ground truth" for the device's performance relates to its physical output (e.g., light wavelength, heat generation) and safety features, which would be measured against engineering specifications or known safety standards, not an expert-derived ground truth or pathology.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that would involve a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device that would involve a training set.
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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: tabsii@msn.com
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.
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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.
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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.
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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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). You may obtain other
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general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll free number (800) 638-2041 or (301) 443-6597, 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
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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
§ 872.6475 Heat source for bleaching teeth.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.