APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W

K070373 · Apoza Enterprise Co., Ltd. · EBZ · Mar 2, 2007 · Dental

Device Facts

• Record ID: K070373
• Device Name: APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W
• Applicant: Apoza Enterprise Co., Ltd.
• Product Code: EBZ · Dental
• Decision Date: Mar 2, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

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

Device Story

Handheld dental curing light; emits blue light (440-490nm) to polymerize light-curing dental resins. Components include handy unit, light guide, optical fiber, and switching power adaptor (some models include Li-ion battery). Operated by dental professionals in clinical settings. Integrated control circuit manages output power, timing, and LED temperature monitoring. Device provides high-intensity light to treatment area; enables hardening of restorative dental materials.

Clinical Evidence

Bench testing only. Device conforms to IEC 60601-1 (safety) and IEC 60601-1-2 (EMC) standards.

Technological Characteristics

Blue LED light source; 440-490nm wavelength; Li-ion battery (3.7V, 2350mAH) or AC power adaptor; optical fiber light guide; programmed control circuit for power/timing/thermal monitoring. Standards: IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for the optical polymerization of light-curing dental resins in a clinical setting. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• LED Turbo-Pen (K041303)

Submission Summary (Full Text)

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### 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: | [phone] |
| | [phone] |
| Fax: | |
| Contact: | Mr. Shih Min-Teh |

| 2. Device Name : | |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | APOZA LED Curing Light--also called APOZA Dental Curing Light<br>-- (Family Model# E-MorLit , D-2000 , TOP 3W, TOP 5W) |
| Common Name: | Dental Curing Light |
| Classification<br>name | activator, ultraviolet, for polymerization |
| 3. DEVICE CLASS | APOZA LED Curing Light , also called APOZA Dental Curing<br>Light , (Family Model# E-MorLit , D-2000 , TOP 3W, TOP<br>5W) have been classified as |
| | Regulatory Class: II |
| | Panel: Dental |
| | Product Code: EBZ |
| | Regulation Number: 21CFR 872.6070 |
| 4. Predicate<br>Device: | The predicate device is the<br>• LED Turbo-Pen (K#041303)<br>marketed by APOZA ENTERPRISE CO. LTD. |
| 5. Intended Use: | APOZA LED Curing Light (Family: Model# E-MorLit ,<br>D-2000 , TOP 3W, "TOP 5W") with blue LED is a device which<br>generating high intensity light for polymerization of<br>light-curing materials used for dental curing purpose.<br>Unlike Halogen light generating full light spectrum, it only<br>emits light with wavelength mainly in the range of 440 to<br>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.

- 7. 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 [phone]. 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 [phone] or [phone] 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

K070373