MIRACLE 98

{0}------------------------------------------------ K03/010 ## JUN 2 5 2003 510(K) SUMMARY Submitter of 510(k): SB LUCIUS, INC. 9778 Katella Ave. 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: | March. 26, 2003 | | Trade name: | MIRACLE 98 | | Common: | Dental casting alloy | | Classification name: | Gold based alloys and precious metal alloys for clinical use | | Product code: | EJT | | Classification: | Class II | Legally marketed device: Heraeous Kulzer's Jel Bios Pure 510(k) number: K002645 ## SJMMARY OF THE TECHNOLOGICAL CHARACTERISTICS Tixst methods applied: as in ANSI/ADA 5 and ISO 9693 Comparison of composition: #### COMPOSITION (WEIGHT) | Device Name | Au (%) | Pt (%) | In (%) | Zn (%) | |---------------|--------|--------|--------|--------| | Jel Bios Pure | 99.30 | <1.0 | <1.0 | <1.0 | | Ceranum 98 | 97.60 | 2.1 | <1.0 | <1.0 | #### 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) | |---------------|-----------------------------|-----------------------|----------------------------|-------------------|-------------------|--------------------| | Jel Bios Pure | 1,900-2,010 | 50 | 55,000 | 45.0 | 15.3 | 19.2 | | Miracle 98 | 1,904-2,015 | 45 | 54,000 | 50.0 | 15.1 | 19.2 | {1}------------------------------------------------ #### Discussion: Sirice 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. MIRACLE 98 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for single unit with lower fusing porcelains and indirect restorative composites. MIRACLE 98 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 MIRACLE 98 is a substantially equivalent to Heræous Kulzer's "el Bios Pure". These changes do not affect safety or effectiveness. Statement of indication for use: MIRACLE 98 is intended for manufacturing: - Porcelain to metal fabrication of single units {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three wavy lines, which are meant to represent the human form. Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 2 5 2003 Ms. Dae-Kyu Chang President SB Lucius, Incorporated 9778 Katella Avenue, Suite 205 Anaheim, California 92804 Re: K031010 Trade/Device Name: MIRACLE 98 Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: March 26, 2003 Received: March 31, 2003 Dear Ms. 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. {3}------------------------------------------------ Page 2 - Ms. Chang 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 vour 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. 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 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. Susan Ruane Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ SB LUCIUS,INC. 9778 Katella Ave. Ave. Ste 205, Anaheim, CA 92804 Phone: (714) 530-2814, Fax : (714) 530-3448, # INDICATIONS FOR USE 510(K) Number : K031010 [Device Name(s) : MIRACLE 98 MIRACLE 98 is intended for manufacturing : - Porcelain to metal fabrication of single units ### (PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) text CONCURRENCE OF CHRD,OFFJCE OF VICE EVALUATION(OED) . General H 510(k) Number: K 031012