CERANUM 87

{0}------------------------------------------------ KO21947 AUG 2 6 2002 #### 510(K) SUMMARY Submitter of 510(k): Lucius Metals Com. 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: | CERANUM 87 | |----------------------|-----------------------------------------------------------------| | 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: DEGUDENT GS 510(k) number: K905387 ## SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS Test methods applied: as in ANSI/ADA 5 and ISO 9693 Comparison of composition: | COMPOSITION (WEIGHT) | | | | | |----------------------|--------|--------|--------|--------| | | Au (%) | Pt (%) | Pd (%) | In (%) | | Degudent GS | 86.00 | 9.70 | 2.20 | 2.0 | | Ceramum87 | 86.95 | 8.87 | 1.15 | 1.0 | ## POSITION MICICUTY ### Comparison of physical and mechanical properties: | Alloy | Melting Point<br>Range (°F) | Hardness<br>(Vickers) | Yield<br>Strength<br>(psi) | Elongation<br>(%) | CTE<br>(x10-6/°C) | Density<br>(g/cm3) | |----------------|-----------------------------|-----------------------|----------------------------|-------------------|-------------------|--------------------| | Degudent<br>GS | 1,949-2,174 | 155 | 58,000 | 8.0 | 14.4 | 18.5 | | Ceranum87 | 2,008-2,079 | 150 | 53,600 | 9.0 | 13.4 | 18.6 | {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. CERANUM 87 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for inlays, onlays, single crowns, bridge, implant superstructures and substrate for medium expansion with lower fusing porcelains and indirect restorative composites. CERANUM 87 is a high gold ceramic alloy, which heightens the porcelain esthetics of the restoration and provides strength, durability and color of gold. Despite minor differences in the materials, we believe that CERAUM 87 is a substantially equivalent to DEGUSSA AG's DEGUDENT GS. These changes do not affect safety or effectiveness. Statement of indication for use: CERANUM 87 is intended for manufacturing: - -Inlay / Onlays - -Crowns - Bridges - - -Implant superstructures {2}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of an eagle or bird, with three stylized lines forming the body and wings. AUG 2.6 2002 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Dae-Kyu Chang Manager Lucius Metals Com. 4241 Farquhar Avenue, #2 Los Alamitos, California 90720 Re: K021947 Trade/Device Name: CERANUM 87 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 Internetaddress http://www.fda.qov/cdrh/dsma/dsmamain.html Sincerely yours, Timothy A. Ulatowski 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}------------------------------------------------ Koz1947 # STATEMENT OF INDICATION FOR USE : CERANUM 87 is intended for manufacturing: - Inlay / Onlays ・ - Crowns - - Bridges - - Implant superstructures - Robert Spetz DDS for Dr. Susan Sumner (Division Sign-Off) (Division Sign-Off) Division of Anesthesiology, General Hospital, Division Ocetrol, Deptal Devices Division of Anesthoolors.org Infection Control, Dental Devices 510(k) Number: K021947