(22 days)
K#041303
Not Found
No
The description focuses on basic electronic control circuits for power, timing, and temperature, with no mention of AI or ML capabilities.
No
The device is used for the optical polymerization of dental resins, a process that hardens dental materials, rather than directly treating a disease or condition in a patient.
No
The device is described as a dental curing light used for the optical polymerization of dental resins, which is a treatment function, not a diagnostic one.
No
The device description explicitly details hardware components such as a rechargeable Li-ion Battery, switching power adaptor, handy unit, programmed control circuit, high intensity dental blue LED light source, light guide, and optical fiber. This is not a software-only device.
Based on the provided text, the APOZA LED Curing Light is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "optical polymerization of dental resins." This is a process performed directly on a patient's teeth to harden dental materials, not a test performed on a sample taken from the body.
- Device Description: The description details a light source and delivery system for treating a patient's mouth. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health condition
The device is clearly described as a tool used in a dental procedure performed directly on the patient.
N/A
Intended Use / Indications for Use
The APOZA LED Curing Light is a dental curing light that is designed for use in the optical polymerization of dental resins.
Product codes (comma separated list FDA assigned to the subject device)
EBZ
Device Description
APOZA LED Curing Light (Family: Model# E-Morl.it , D-2000 , TOP 3W, TOP 5W) is non-invasive medical device and is designed for use in the optical polymerization of dental resins. APOZA LED Curiing Light deliver 440-490nm blue light.
APOZA LED Curing Light is also called APOZA Dental Curing Light. it includes the following models:
- . E-MorLit consist of a rechargeable Li-ion Battery (DC3.7V ; 2350mAH) in the handy unit and a switching power adaptor (also used as battery charger) ,
- () D-2000 consist of a rechargeable Li-ion Battery (DC3.7V ; 2350mAH) in the handy unit and a switching power adaptor (also used as battery charger)
- () TOP 3W consist of a handy unit and a switching power adaptor.
- () TOP 5W consist of a handy unit and a switching power adaptor.
The handy unit contains a programmed control circuit, high intensity dental blue LEI》 light source, a light quide 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 In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards included IEC 60601-1 and IEC 6060 -1-2 requirements.
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.
K#041303
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
§ 872.6070 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
1 0 5 510(K JMMARY
MAR 0 2 2007
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
| 1. Submitter's | APOZA ENTERPRISE CO. LTD. |
|---|---|
| Name: | 6 F, no.657, Chuang Cheng Road , 242 Hsin-Chuang City Taipei |
| Address: | Hsien , Taiwan |
| Phone: | +886-2-29010620 |
| +886-2-29012208 | |
| Fax: | |
| Contact: | Mr. Shih Min-Teh |
| 2. Device Name : | |
|---|---|
| Trade Name: | APOZA LED Curing Light--also called APOZA Dental Curing Light |
| -- (Family Model# E-MorLit , D-2000 , TOP 3W, TOP 5W) | |
| Common Name: | Dental Curing Light |
| Classification | |
| name | activator, ultraviolet, for polymerization |
| 3. DEVICE CLASS | APOZA LED Curing Light , also called APOZA Dental Curing |
| Light , (Family Model# E-MorLit , D-2000 , TOP 3W, TOP | |
| 5W) have been classified as | |
| Regulatory Class: II | |
| Panel: Dental | |
| Product Code: EBZ | |
| Regulation Number: 21CFR 872.6070 | |
| 4. Predicate | |
| Device: | The predicate device is the |
| • LED Turbo-Pen (K#041303) | |
| marketed by APOZA ENTERPRISE CO. LTD. | |
| 5. Intended Use: | APOZA LED Curing Light (Family: Model# E-MorLit , |
| D-2000 , TOP 3W, "TOP 5W") with blue LED is a device which | |
| generating high intensity light for polymerization of | |
| light-curing materials used for dental curing purpose. | |
| Unlike Halogen light generating full light spectrum, it only | |
| emits light with wavelength mainly in the range of 440 to | |
| 490nm, namely, the applicable range for dental curing of |
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6. Device Description:
APOZA LED Curing Light (Family: Model# E-Morl.it , D-2000 , TOP 3W, TOP 5W) is non-invasive medical device and is designed for use in the optical polymerization of dental resins. APOZA LED Curiing Light deliver 440-490nm blue light.
APOZA LED Curing Light is also called APOZA Dental Curing Light. it includes the following models:
- . E-MorLit consist of a rechargeable Li-ion Battery (DC3.7V ; 2350mAH) in the handy unit and a switching power adaptor (also used as battery charger) ,
- () D-2000 consist of a rechargeable Li-ion Battery (DC3.7V ; 2350mAH) in the handy unit and a switching power adaptor (also used as battery charger)
- () TOP 3W consist of a handy unit and a switching power adaptor.
- () TOP 5W consist of a handy unit and a switching power adaptor.
The handy unit contains a programmed control circuit, high intensity dental blue LEI》 light source, a light quide 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.
-
- Performance In terms of operating specification, Safety & EMC requirements, Summary: the device conforms to applicable standards included IEC 60601-1 and IEC 6060 -1-2 requirements.
8. Conclusions:
APOZA LED Curing Light (Family: Model# E-MorLit , D-2000 , TOP 3W, TOP 5W ) has the same intended use and technological characteristics as the LED Turbo-Pen (K#041303) previously marketed by the submitter -- APOZA ENTERPRISE CO. LTD. Moreover, berich testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveriess. Thus, APOZA LED Curing Light (Family: Model# E-MorLit , D-2000 , TOP 3W, TOP 5W) is substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized depiction of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Apoza Enterprise Company, Limited C/O Ms. Jennifer Reich Harvest Consulting Corporation 2904 North Boldt Drive Flagstaff, Arizona 86001
MAR 0 2 2007
Re: K070373
Trade/Device Name: APOZA LED Curing Light (Model# E-MorLit, D-2000, TOP 3 W. TOP 5W) APOZA ENTERPRISE CO. LTD. Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: January 25, 2007 Received: February 8, 2007
Dear Ms. Reich:
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.
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Page 2 – Ms. Reich
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 (240) 276-0115. 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 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/industry/support/index.html.
Sincerely yours,
Susan Evans
Chiu Lin, Ph.D. 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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Indication® for Use
510(k) Number (if known):_ 3670373
Device Name: APOZA LED Curing Light (Model# E-MorLit , D-2000 , TOP 3W, APOZA ENTERPRISE CO. LTD. TOP 5W)
Indications For Use:
The APOZA LED Curing Light is a dental curing light that is designed for use in the optical polymerization of dental resins.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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 (ODE)
Susa Ringe
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Control, Dantal Devio