(91 days)
Not Found
Not Found
No
The device description focuses on the light source and safety features, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is described as a tooth whitening system and its intended use is a light source for bleaching teeth, which is considered a cosmetic or aesthetic purpose rather than treating or preventing a disease or condition.
No
Explanation: The device is intended for teeth whitening by providing a light source to activate a whitening gel. It is not described as diagnosing any condition or disease.
No
The device description explicitly states the system consists of a handheld, battery-operated light device, a whitening gel, and preconditioning mouthwash, indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a light source for bleaching teeth." This is a direct application to the body (teeth) for a cosmetic/aesthetic purpose (whitening).
- Device Description: The description details a handheld light device, whitening gel, and mouthwash used externally on the teeth.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a person's health. This device does not involve the analysis of such specimens.
The device is a light source used externally on the teeth to activate a whitening gel, which is a cosmetic procedure. This falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for 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.
The Dentovations South Beach Smile Light Whitening System is intended for use as a light source for bleaching teeth.
Product codes (comma separated list FDA assigned to the subject device)
EEB
Device Description
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 Whitening Light has been tested and proven to be safe for the consumer to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
consumer and dental professions
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
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.
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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 (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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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 (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