APOZA CURING LIGHT, Models: LA500 Blue Light. The intended use of the LA500 Blue Light is for the polymerization of light cure material and activation of dental bleaching materials.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for a dental curing light, primarily focusing on its equivalence to a predicate device and its intended use. There is no mention of specific performance metrics, test sets, ground truth establishment, or expert involvement in a study.

Summary

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5. 510(K) SUMMARY

DEC - 2 2003

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APOZA CURING LIGHT, Models: LA500 Blue Light

510K:

APOZA ENTERPRISE CO., LTD. Submitted by: 6F, No.657, Chuang Cheng Road, Hsin-Chuang City, Taipei Hsien, China (Taiwan) Contact person: Mr. Shih, Min-Teh Apoza Enterprise Co., Ltd. 6F, No.657, Chuang Cheng Road, Hsin-Chuang City, Taipei Hsien, China (Taiwan)
Date Summary Prepared: September 27, 2003 .
- Classification name: Activator, Ultraviolet, for Polymerization
Classification number: EBZ, Class II
. Regulation Number: 872.6070
- Proprietary name: APOZA CURING LIGHT, LA500 Blue Light
Common name of device: . CURING LIGHT
. Predicate Device: Kerr Corporation

Optilux 501

510K No - K020091

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Statement of Intended Use: APOZA CURING LIGHT, LA500 Blue Light

The intended use of the LA500 Blue Light is for the polymerization of light cure material and activation of dental bleaching materials.

Comparison to Predicate Devices: The APOZA CURING LIGHT, LA500 Blue

Light, have been carefully compared to legally marketed devices with respect to intended use and technological characteristics. In addition, performance testing has been done to validate the performance of the device. The comparison and validation results presented in this 510k notification to the FDA show that the subject device is substantially equivalent to predicated device and is safe and effective in its intended use.

We believe that the APOZA CURING LIGHT, LA500 Blue Light is substantially equivalent to the predicate device, i.e., KERR CORPORATION OPTILUX 501 in K.020091, and the data provided support the safety and effectiveness of LA500 for the intended uses.

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Public Health Service

DEC - 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Min-Teh Shih General Manager Apoza Enterprise Company, LTD 6F, 657, Chung-Cheng Road Hsin-Chuang City, Taipei Hsicn, 242 Taiwan, CHINA

Re: K033201

Trade/Device Name: LA500 Blue Light Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: September 27, 2003 Received: October 02, 2003

Dear Mr. Shih:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 3 l'0(x) premails. In anywards (tfor the indications for referenced above and have determilied the increase devices marketed in interstate commerce
use stated in the enclosure) to legally marketed pedical a mandments, or to devices use stated in the enclosure) to legally filation products and mentments, or to devices that prior to May 28, 1976, the enacthem date of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal Food, You may. have been reclassified in accordance with the provisions wal application (PMA). You may,
Act (Act) that do not require approval of a premarks approval application of the Act Act (Act) that do not require approval of a prematiconspissions of the Act. The general
therefore, market the device, subject to the general controls provisions of the Act. T therefore, market the device, subject to the generation, list negativation, listing of devices, good
controls provisions of the Act include requirements for any adulteration. controls provisions of the Act mende requirements for and adulteration.
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 If your device is classified (see above) into Euro regulations affecting your device can be
may be subject to such additional controls. Existing mayor regulations FDA may may be subject to such additional controls. 1:21stilly nagor 89% In addition, FDA may publish
found in the Code of Federal Regulations, Title 21, Parts 800 to 89% In addi found in the Code of I cacral regginations, which in the Federal Register.

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Page 2 - Mr. Min-Teh Shih

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. non 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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4. INDICATIONS FOR USE STATEMENT

Applicant :	APOZA Enternrise CoI to
510(k) Number :	TO DE .

Device Name : APOZA CURING LIGHT, LA500 Blue Light

Indications for Use :

LA500 Blue Light is a visible curing unit programmed for This polymerization of light cured materials by dental professionals..

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use Per 21 CFR 801.109

Over-The-Counter (Optional Format 1-2-96)

General Hospital. Infection Control, Dental

510(k) Number:_

Regulation Number and Section

§ 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.