LUCIUS 62

{0}------------------------------------------------ K021948 SEP = 3 2002 ## 510(K) SUMMARY OF STATEMENT Lucius Metals Com. Submitter of 510(k): 4241 Farquhar Ave. #2, Los Alamitos, CA 90720 Phone/Fax: (562) 799-6626, Cell: (562) 477-0155 | Contact person: | Dae Kyu Chang | |-----------------|---------------------| | Phone: | (562) 799-6626 | | Fax: | (562) 799-6626 | | E-mail: | Gatorkr@yahoo.co.kr | Date of Summary: June 5, 2002 | Trade name: | LUCIUS 62 | |----------------------|-----------------------------------------------------------------| | Common: | Dental casting alloy | | Classification name: | Gold based alloys and precious metal alloys for<br>clinical use | | Product code: | EJT | | Classification: | Class II | Legally marketed device: Jel-62 510(k) number: K874308 Test methods applied: as in ANSI/ADA 5 and ISO 9693 Comparison of composition: | | 101 ·<br>iul | Pt(% | 1 / 0 / 0 / 1 / 0 / 1 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0<br>10 | ~101 | 101<br>oul | |------------------|--------------|------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|------------| | -60<br>lel-UL | 00 00 | 0.00 | 3.00 | 06<br>20. | 3.0 | | ે જિ<br>_ucius & | ۵۹ ۱۳۹ | 0.00 | 500 | 26.00 | | Comparison of physical and mechanical properties: | Alloy | Melting Point<br>Range(°F) | Hardness<br>(Vickers) | Yield Strength<br>(psi) | Elongation<br>(%) | Density<br>(g/cm3) | |-----------|----------------------------|-----------------------|-------------------------|-------------------|--------------------| | Jel-62 | 1,598-1,724 | 170 | 42,000 | 45.0 | 14.3 | | Lucius 62 | 1,652-1,710 | 150 | 40,600 | 33.1 | 14.1 | Discussion: Since the composition of the legally marketed alloy and the new device is very similar, it may be assumed that the biological compatibility of the alloys is also very similar. {1}------------------------------------------------ Conclusion: The main elements and their concentration are almost identical. LUCIUS 62 is a platinum-free crown and bridge alloy. This device is dependable 62% gold alloy with a high gold appearance. LUCIUS 62 is excellent for inlays, three-quarter crowns, long and short-span bridges. LUCIUS 62 is substantially equivalent to JELENKO'S Jel-62, and the minor differences between them do not affect safety or effectiveness. Statement of indication for use: LUCIUS 62 is intended for manufacturing - Inlay / Onlays ・ - Crowns - - Short span bridges - - -Long span bridges - Removable partials - {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top half of the circle. The text is in all capital letters and is evenly spaced around the curve of the circle. Food and Drug Administration -9200 Corporate Boulevard Rockville MD 20850 SEP - 3 2002 Mr. Dae Kyu Chang President Lucius Metals Company 4241 Farquhar Avenue, # 2 Los Alamitos, California 90720 Re: K021948 Trade/Device Name: LUCIUS 62 Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: June 5, 2002 Received: June 13, 2002 Dear Mr. Chang: 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. 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. {3}------------------------------------------------ Page 2 - Mr. Chang 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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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 yours, Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Kuz1948 ## STATEMENT OF INDICATION FOR USE LUCIUS 62 is intended for manufacturing: - Inlay / Onlays - - Crowns - - Short span bridges - - Long span bridges - - Removable partials - Susa Runges (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: k021941