(32 days)
Not Found
No
The description mentions a "programmed control circuit" which governs basic functions like power, timing, and temperature monitoring. There is no mention of AI, ML, image processing, or any learning capabilities. The performance studies focus on the curing capabilities of the LED technology, not on any AI/ML-driven analysis or decision-making.
No.
The device is used for the optical polymerization of dental resins, which is a process in dental restorative procedures, not directly for treating or alleviating a disease or condition in a patient.
No
Explanation: The device is a dental curing light used for the optical polymerization of dental resins and activation of tooth bleaching agents. Its function is to perform a therapeutic or procedural action (curing/bleaching), not to diagnose a condition or disease.
No
The device description explicitly states it consists of a "handy unit" and a "battery charger," which are hardware components. It also describes a "high intensity dental blue LED light source," "light guide," and "optical fiber," all of which are physical parts of the device.
Based on the provided information, the LED Turbo-Pen is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "optical polymerization of dental resins," which is a treatment procedure performed directly on a patient's teeth.
- Device Description: The device description details a light source and delivery system for curing dental materials in situ.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The LED Turbo-Pen does not perform any such analysis of specimens.
The device is clearly a therapeutic device used in a dental setting for a treatment procedure.
N/A
Intended Use / Indications for Use
The LED Turbo-Pen is a dental curing light that is designed for use in the optic polymerization of dental resins. The LED Turbo-Pen is a dental curing light that is designed for use in the optical polymerization of dental resins.
Product codes
EBZ
Device Description
The LED Turbo-Pen 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-Pen 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-Pen
(family: LED Turbo-Pen, TOP Light, TOP Light PLUS, KO4 1303
TOP Light Turbo) JUN 1 8 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: Apr 1, 2004
- 8.7 Trade name/proprietary name: LED Turbo-Pen
(family: LED Turbo-Pen, TOP Light, TOP Light PLUS, TOP Light 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-Pen | ||
| (family: LED Turbo-Pen, | ||
| TOP Light, TOP Light | ||
| PLUS, TOP Light Turbo) | Dental curing light | Ultraviolet activator for |
| polymerization |
8.10 Legally market device equivalence:
Device name: Led Turbo 510k number: K040618 Manufacturer: APOZA Enterprise, Co,.Ltd.
8.11 Intended use:
The LED Turbo-Pen is a dental curing light that is designed for use in the optic polymerization of dental resins.
1
8.12 Device description
The LED Turbo-Pen 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.
| LED Turbo-Pen | Led Turbo | |
|---|---|---|
| 1. Light Intensity | 500~1600mW/cm² | 1600mW/cm² |
| 2. Output Wave | ||
| length | 440nm~490nm | 440nm~490nm |
| 3. LED power | ||
| consumption | 1 Watt and 5Watt | 5 Watt |
| 4. Battery use | 7.2V/1900mAh | 7.2V/1900mAh |
| 5. Operating Voltage | AC100V~260V 50/60Hz | AC100V~260V 50/60Hz |
| 6. Curing time | 5, 10, 20, 40 seconds selectable | 5, 10, 20, 40 seconds selectable |
8.14 Comparison with equivalence marketed device:
Both the LED Turbo-Pen 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-Pen and the predicate curing lights is the intensity of the light power delivered. The increased light intensity of the proposed LED Turbo-Pen 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-Pen 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-Pen and LED Turbo to a conclusion of substantial equivalence between the proposed and predicate devices.
2
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.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 8 2004
Mr. Shin Min-Teh General Manager Apoza Enterprise Company, LTD 6F, 657, Chung-Cheng Road Hsin-Chuang City, Taipei Hsien, 242 Taiwan, CHINA
Re: K041303
Trade/Device Name: LED Turbo-Pen Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: May 01, 2004 Received: May 17, 2004
Dear Mr. Min-Teh:
We have reviewed your Section 510(k) premarket notification of intent to market the device in indicati we nave revewed your Section 910(R) premained houbstantially equivalent (for the indications for referenced above and have decemined the essee predicate devices marketed in interstate winest the t use stated in the encreative to regarly manolical Device Amendments, or to devices that prior to May 26, 1770, the chaemient with the provisions of the Federal Food, Drug, and Cosmetic have been reclassified in accordance will at a proval application (PMA). You may, Act (Act) that do not require approval or a provisions of the Act. The Act. The eeneral therefore, market the device, subject to the general for annual registration, listing of devices, good Controls provisions of the necessary and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see ao re) into existing major regulations affecting your device can be may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may publish found in the Seconderning your device in the Federal Register.
3
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA S Issualice of a successfiel with other requirements of the Act of that FDA has made a deletinination that your are room Federal agencies. You must comply with any Federal statures and regulations administered of to: registration ond listing (21 CFR Part 807);
all the Act's requirements, including, but not limited to: rest set forth all the Act s requirements, but not rime in the requirements as set forth in the quality
labeling (21 CFR Part 801); good manufacturer in the colors and until sediation labeling (21 CFR Part 801), good manazating production, the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product systems (QB) regalaxes (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) I his letter will anow you to ocgin marketing of substantial equivalence of your device to a legally premarket nothleation. The PDA miding of backannal or some of this, 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
s the promotion of the 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 1 if you desire specific advice for your device on on and time of the promotions on the promotion contact the Office of Compliance at (301) 594-4039 Compliance at (301) 594-4639. Also, Sales (131 CED and advertising of your device, prease corract in 5 oreference to premarket notification under the Ast ma please note the regulation entitled, "Misoralians" of responsibilities under the Act may Part 807,97) you may obtain. Other general informational and Consumer Assistance at its be obtained from the DFABICS 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
4
Indications for Use
510(k) Number (if known): K041303
Device Name: LED Turbo-Pen Indications for Use:
The LED Turbo-Pen is a dental curing light that is designed for use in the optical polymerization of dental resins.
Prescription Use J × (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)
Susan Ruane
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:_
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