LUCIUS 76

{0}------------------------------------------------ #### 1 2002 NOV # 10223196 #### 510(K) SUMMARY Submitter of 510(k): SB LUCIUS, INC. 9778 Katella Ave. Ste, 205, Anaheim, CA 92804 Phone: (714) 530-2814, Fax : (714) 530-3448, | Contact person: | Dae-Kyu Chang | |------------------------------------------------|------------------------------------------------------------------------------------------------------| | Phone: | (714) 530-2814 | | Fax: | (714) 530-3448 | | E-mail: | Gatorkr@yahoo.co.kr | | Date of Summary: | Sept. 16, 2002 | | Trade name:<br>Common:<br>Classification name: | LUCIUS 76<br>Dental casting alloy<br>Gold based alloys and precious metal alloys for<br>clinical use | | Product code: | EJT | | Classification: | Class II | Legally marketed device: Argen's ARGENCO 77** 510(k) number: 893385 # SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS Test methods applied: as in ANSI/ADA 5 and ISO 9693 ### Comparison of composition: | COMPOSITION (WEIGHT,%) | | | | | | | |------------------------|--------|--------|--------|--------|-------|-------| | Device Name | Au (%) | Pt (%) | Pd (%) | Ag (%) | CU(%) | ZN(%) | | Argenco 77** | 76.0 | 1.0 | - | 13.0 | 8.45 | <1.0% | | LUCIUS 76 | 76.0 | 1.0 | 2.0 | 11.3 | 9.99 | 0.68 | ### COMPOSITION (WEIGHT %) ### Comparison of physical and mechanical properties: | Alloy | Melting Point<br>Range (°F) | Hardness<br>(Vickers) | Yield Strength<br>(MPa) | Elongation<br>(%) | |--------------|-----------------------------|-----------------------|-------------------------|-------------------| | Argenco 77** | 1,650-1,715 | 120 | 286 | 40.0 | | LUCIUS 76 | 1,746-1,814 | 148 | 270 | 48.0 | {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. #### Conclusion: The main elements and their concentration are almost identical. LUCIUS 76 is a platinum-free crown and bridge alloy. This device is dependable 76% gold alloy with a high gold appearance. LUCIUS 76 is an excellent for inlays, three-quarter crowns, long and short-span bridges. LUCIUS 76 is a substantially equivalent to Argen's Argenco 77**, and the minor differences between them do not affect safety or effectiveness. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is centered on the image. The font is a simple sans-serif font. The text is likely the header of a document or website. Food and Drug Administrat 9200 Corporate Boulevard Rockville MD 20850 #### NOV 1 2002 Mr. Dae-Kyu Chang SB Lucius, Incorporated · 9778 Katella Avenue, Suite 205 Anaheim, California 92804 Re: K023196 Trade/Device Name: LUCIUS 76 Regulation Number: 21 CFR 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: September 16, 2002 Received: September 25, 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 vour 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}------------------------------------------------ # B LUCIUS,INC Ste. 205, Anaheim, CA 92804 9778 Katella Ave. Phone: (714) 530-2814 Fax : (/14) 530-3448 ### INDICATIONS FOR USE 510(K) Number : K023196 Device Name(s) : Lucius 76 This is a yellow casting alloy for inlay / onlays, crowns, short span bridges, long span bridges, removable partials. (PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) CONCURRENCE OF CHRD,OFFICE OF DEVICE EVALUATION(OED) Susan Pierce (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number K033196