(82 days)
Not Found
No
The description focuses on the light source and safety features, with no mention of AI or ML capabilities.
No
The device is described as a heat source for bleaching teeth and a tooth whitening system, which are cosmetic procedures, not therapeutic.
No.
The "Intended Use / Indications for Use" states that the device is intended to "provide a heat source for bleaching teeth," which is a treatment function, not a diagnostic one. The "Device Description" further clarifies it as a "tooth whitening system."
No
The device description clearly describes a physical light unit ("stand alone unit") that emits light and heat, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This includes tests for diagnosis, monitoring, screening, and prognosis.
- Device Function: The QuickSmile light is a device that emits light to provide heat for bleaching teeth. It acts directly on the teeth (an anatomical site) and does not involve the analysis of specimens taken from the body.
- Intended Use: The intended use is for tooth whitening, which is a cosmetic or aesthetic procedure, not a diagnostic test.
Therefore, the QuickSmile light falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The QuickSmile light is intended to emit light in the 600-700 nanometer spectrum to provide a heat source for bleaching teeth.
Product codes (comma separated list FDA assigned to the subject device)
EEG
Device Description
The QuickSmile light is intended for use by a dental professional as a tooth whitening system. The whitening light heat source is a stand alone unit which emits a biologically safe and effective level of red 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 600-700 nanometers. The LED light emits approximately 1º-3º C heat against the tooth surface. To ensure user safety when operating the light, the light has built in features to eliminate any risk for the end user and dental professional. First, the light automatically shuts off after a specified period of time designated by the dental professional. Secondly, the light is supplied with specially designed safety glasses for the patient and dental professional that stop the penetration of the red/orange wavelength and protect the vision of the patient and dental professional.
The Light Emitting Diodes (LED's) which are the basis of the QuickSmile whitening system are Red-Orange (613.5nm - 620.5nm) and each diode produces a typical 55 lumens per watt. Thus, the bank of 12 diodes in the adjustable head of the QuickSmile light produces about 660 lumens, a safe and effective light source for the teeth whitening process.
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
Dental professional
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.
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.
0
OCT 1 8 2005
K6 5 2040
Cosmetic Dental Materials QuickSmile Whitening Light Original Premarket 510(K) Notification
SECTION 9: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(K) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR.807.92.
9.1 SUBMITTER INFORMATION
| a. Submitter Name: | Cosmetic Dental Materials Inc.
(CDM Inc.) |
|---------------------------|----------------------------------------------|
| b. Submitter Address: | 812 Water St. NE
Albany OR 97321 |
| c. Submitter Telephone: | (541)928-4444 |
| d. Submitter Facsimile: | (541)928-2444 |
| e. Contact Person: | Bob Bowers
Chief Operating Officer |
| f. Date Summary Prepared: | June 17th 2005 |
| EVICE IDENTIFICATION | |
9.2 DEVICE IDENTIFICATION
| a. Trade/Proprietary Name: | QuickSmile |
|---|---|
| b. Classification Name: | Heat Source for Bleaching Teeth |
| 21 CFR 872.6475 |
9.3 IDENTIFICATION OF PREDICATE DEVICES
The QuickSmile light is substantially equivalent to the South Beach Smile Light Whitening System by Dentovations Inc of Boston MA (510K #K042153).
1
Cosmetic Dental Materials QuickSmile Whitening Light Original Premarket 510(K) Notification
9.4 DEVICE DESCRIPTION
The QuickSmile light is intended for use by a dental professional as a tooth whitening system. The whitening light heat source is a stand alone unit which emits a biologically safe and effective level of red 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 600-700 nanometers. The LED light emits approximately 1º-3º C heat against the tooth surface. To ensure user safety when operating the light, the light has built in features to eliminate any risk for the end user and dental professional. First, the light automatically shuts off after a specified period of time designated by the dental professional. Secondly, the light is supplied with specially designed safety glasses for the patient and dental professional that stop the penetration of the red/orange wavelength and protect the vision of the patient and dental professional.
9.5 SUBSTANTIAL EQUIVALENCE
The QuickSmile product is a Light Emitting Diode (LED) light that emits light in the 600-700 nanometer spectrum to provide a heat source for the bleaching of teeth. The QuickSmile light is substantially equivalent to other tooth whitening lights currently in commercial distribution such as the BriteSmile and Discus Dental Zoom light. For the purpose of this 510K, the QuickSmile light will be shown to be substantially equivalent to the South Beach Smile Light Whitening System by Dentovations Inc of Boston MA (510K #K042153).
9.6 INDICATIONS FOR USE
The QuickSmile light is intended to emit light in the 600-700 nanometer spectrum to provide a heat source for bleaching teeth.
9.7 TECHNOLOGICAL CHARACTERISTICS
The Light Emitting Diodes (LED's) which are the basis of the QuickSmile whitening system are Red-Orange (613.5nm - 620.5nm) and each diode produces a typical 55 lumens per watt. Thus, the bank of 12 diodes in the adjustable head of the QuickSmile light produces about 660 lumens, a safe and effective light source for the teeth whitening process.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular pattern around the symbol. The logo is black and white.
OCT 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert Bowers Chief Operating Officer Cosmetic Dental Materials, Incorporated 812 Water Street N.E. Albany, Oregon 97321
Re: K052040 Trade/Device Namc: QuickSmile Regulation Number: 21 CFR 872.6475 Regulation Name: Heat Source for Bleaching Teeth Regulatory Class: I Product Code: EEG Dated: October 05, 2005 Received: October 06, 2005
Dear Mr. Bowers:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the 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: malachite green oxalate. In late 1991, the Food and Drug 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). 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 contain adequate scientific data, including clinical trials, which establish that a product is safe and effective for its intended use.
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 malachite green oxalate, the whitening component of your device, is unresolved at this time.
3
Page 2 – Mr. Robert Bowers
Our substantially equivalent determination does not apply to the whitening component(s) of vour 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 docs 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 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.
Sincercly vours.
ch
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
unmer
4
Indications for Use
510(k) Number (if known): K052040
Device Name: QuickSmile Indications for Use:
The QuickSmile light is intended to emit light in the 600-700 nanometer spectrum to provide a heat source for bleaching teeth.
Prescription Use X (21 CFR Part 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sydne Rumm
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Division of Ancolnoclorology
Infection Control, Dental Devices
510(k) Number _
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