CERANUM 90

{0}------------------------------------------------ #### 1 2002 NOV K023198 ## 510(K) SUMMARY Submitter of 510(k): SB LUCIUS, INC. Ste.205, Anaheim, CA 92804 9778 Katella Ave. 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: | CERANUM 90 | | 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 Bios 90 510(k) number: K001196 ## SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS Test methods applied: as in ANSI/ADA 5 and ISO 9693 #### Comparison_of composition: | Device Name | Au | Pt | Pd | Ag | CU | Sn | FE | Zn | |-------------|-------|------|-------|------|-----|------|------|------| | Jel Bios 90 | 90.00 | 7.40 | - | 1.0 | - | - | <1.0 | <1.0 | | Ceranum 90 | 90.00 | 4.00 | 11.95 | 0.05 | 0.2 | 0.40 | 0.15 | 1.00 | #### COMPOSITION (WEIGHT %) ## Comparison of physical and mechanical properties: | Alloy | Melting Point<br>Range (°F) | Hardness<br>(Vickers) | Yield<br>Strength<br>(MPa) | Elongation<br>(%) | CTE<br>(x10-6/°C) | Density<br>(g/cm3) | |-------------|-----------------------------|-----------------------|----------------------------|-------------------|-------------------|--------------------| | Jel Bios 90 | 1,920-2,085 | 160.0 | 386 | 8.0 | 14.6 | 18.8 | | Ceranum 90 | 2,012-2,102 | 145.7 | 255 | 16.76 | 15.03 | 19.25 | {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 90 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 90 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 CERANUM 90 is a substantially equivalent to J.F.JELENKO's Jel Bios 90. These changes do not affect safety or effectiveness. {2}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows a seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is facing to the right. The image is black and white. d and Drug Administration Corporate Boulevard ckville MD 20850 Mr. Dae-Kyu Chang SB Lucius, Incorporated 9778 Katella Avenue, Suite 205 Anaheim, California 92804 Re: K023198 Trade/Device Name: Ceranum 90 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 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 (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 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 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}------------------------------------------------ 9778 Katella Ave Ste. 205, Anaheim, CA 92804 Phone: (714) 530-2814, Fax : (714) 530-3448, # INDICATIONS FOR USE 510(K) Number : ______________________________________________________________________________________________________________________________________________________________ Device Name(s) : ceranum 90 This is a yellow ceramic alloy for single units, implants prosthetics, single & 3/4 crowns, and short span bridges. (PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) CONCURRENCE OF CHRD,OFFICE OF DEVICE EVALUATION(OED) - Suvir Rana on Sign-Off) Division of Anesthesiology, General Hospital, Infection Control. Dental Devices 510(k) Number. K(i) RAn