(16 days)
Not Found
No
The description focuses on a programmed control circuit for basic functions like power, timing, and temperature monitoring, which are standard for medical devices and do not indicate AI/ML. There are no mentions of AI, ML, or related concepts like image processing or training/test data.
No
The device is a dental curing light used for polymerization of dental resins and activation of bleaching materials, which are procedures that modify dental materials rather than treating a disease or condition in a therapeutic manner.
No
Explanation: The device is a dental curing light used for polymerization of dental resins and activation of bleaching materials, which are treatment functions, not diagnostic ones.
No
The device description clearly states it consists of a "handy unit" and a "battery charger," which are physical hardware components. It also describes a "high intensity dental blue LED light source," "light guide," and "optical fiber," all of which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "polymerization of dental resins and the activation of bleaching materials." This is a therapeutic/treatment function performed directly on the patient, not a diagnostic test performed on a sample taken from the patient.
- Device Description: The description details a light source and delivery system for treating the patient's teeth. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
Therefore, the LED Turbo is a dental treatment device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LED Turbo is a dental curing light that is designed for use in the optic polymerization of dental resins and activation of bleaching materials.
Product codes
EBZ, EEG
Device Description
The LED Turbo consists of a handy unit and a battery charger. The handy unit contains a programmed control circuit, high intensity dental blue LED light source, a light guide and a optical fiber that conduct light to the treatment area on the patient. The control circuit which governs the output power rate, timing and monitoring the temperature of the LED.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance testing has been conducted that confirms that the halogen light technology used for LED Turbo is able to cure resin and activate tooth bleaching agents within the specified timeframe without causing thermal damage to the tissue.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6070 Ultraviolet activator for polymerization.
(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.
0
8. PREMARKET NOTIFICATION 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FOR CURING LIGHT LED TURBO
MAR 2 5 2004
8.1 Submitter's name: APOZA ENTERPRISE CO., LTD.
8.2 Address: 6F, 657, Chung-Cheng Road, Hsin-Chuang City, 242 Taipei Hsien, Taiwan, ROC.
- 8.3 Phone No:886-2-29010620
- 8.4 Fax No:886-2-29012208
- 8.5 Contact person: Mr. Shin Min Teh
- 8.6 Date prepare: Feb 1, 2004
- 8.7 Trade name/proprietary name: LED Turbo
- 8.8 Common name/usual name: Dental Curing Light
8.9 Classification name: Ultraviolet dental curing light.
| TRADE NAME | COMMON NAME | CLASSIFICATION NAME |
|---|---|---|
| LED Turbo | Dental curing light | Ultraviolet activator for |
| polymerization |
8.10 Legally market device equivalence:
Ultra-Lite 200E Plus 510k number: K023545 Manufacturer: Rolence Enterprise, Inc.
8.11 Intended use:
The LED Turbo is a dental curing light that is designed for use in the optic polymerization of dental resins and activation of bleaching materials.
8.12 Device description
The LED Turbo consists of a handy unit and a battery charger. The handy unit contains a programmed control circuit, high intensity dental blue LED light source, a light guide and a optical fiber that conduct light to the treatment area on the patient. The control circuit which governs the output power rate, timing and monitoring the temperature of the LED.
1
| LED Turbo | Ultra-Lite 200E Plus | |
|---|---|---|
| 1. Light Intensity | 1100mW/cm2 (Min.800mW/cm2) | Min. 800mW/cm2 |
| 2. Output Wave length | 440nm~490nm | 440nm~490nm |
| 3. LED power consumption | 5Watt | 1 Watt |
| 4. battery use | 7.2V/1900mAh | 9.6V/300mAh |
| 5. Operating Voltage | AC100V~260V 50/60Hz | AC110V, AC120V, AC230, 50/60Hz |
| 6.Weight | 380 g | |
| 7.Curing time | 5, 10, 20, 40 seconds selectable | 20 seconds |
8.14 Comparison with equivalence marketed device:
Both the LED Turbo and the predicate curing lights offer multiple curing programs for photopolymerization of dental resins and activation of bleaching materials. These programs differ in the intensity of the light delivered and the length of the light exposure. The operational principles of the proposed and predicate devices are identical. The operator chooses the appropriate program and sets the treatment parameters, if necessary. The tip of handpiece if oriented appropriately relative to the material being photopolymerized, or the tooth surface (for bleaching procedures), and the selected treatment is initiated.
The major difference between the proposed LED Turbo Gun and the predicate curing lights is the intensity of the light power delivered. The increased light intensity of the proposed LED Turbo allows the resin curing and tooth whitening agent activation to be conducted in a much shorter timeframe. Performance testing has been conducted that confirms that the halogen light technology used for LED Turbo is able to cure resin and activate tooth bleaching agents within the specified timeframe without causing thermal damage to the tissue.
The Similarities in intended use, technical specifications, and functional performance between the LED Turbo and Ultra-Lite 200e Plus leads to a conclusion of substantial equivalence between the proposed and predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized graphic 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 graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 5 2004
Mr. Shih Min-Teh General Manager Apoza Enterprise Company, LTD 6F, 657, Chung-Cheng Road Hsin-Chuang City, Taipei Hsien, 242 Taiwan, CHINA
Re: K040618
Trade/Device Name: LED Turbo Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Codes: EBZ and EEG Dated: February 01, 2004 Received: March 10, 2004
Dear Mr. Min-Teh:
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, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval 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 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.
3
Page 2 – Mr. Shih Min-Teh
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. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Carls
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): K040618
Device Name: LED Turbo
Indications for Use:
The LED Turbo is a dental curing light that is designed for use in the polymerization of dental resins and the activation of bleaching materials.
Prescription Use
(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)
Susa Ruong
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
1-12/11, 510(k) Number:
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