UCLA AND CEMENT-ON ABUTMENTS AND ACCESSORIES

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus features a staff with a serpent entwined around it. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 3 0 2004 Ms. Jeff Rassoli President DíamoDent™ 2737 East Regal Park Avenue Anaheim. California 92806 Re: K034022 Trade/Device Name: UCLA and Cement-On Abutments and Accessories Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: December 16, 2003 Received: December 29, 2003 Dear Mr. Rassoli: 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. {1}------------------------------------------------ #### Page 2 - Mr. Rassoli 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 requirences as better as 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), 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 maj Sound 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, Oul Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use #### 510(k) Number (if known): K034022 UCLA and Cement-On Abutments Device Name: ### Indications for Use: The UCLA Abutments and Cement-On Abutments are designed for use with commercially available dental implant systems. These abutments are straight abutments and are NOT angled abutinents. The abutments will scat directly on implants and are sub-structure of prosthesis. Some abutments are used as pattern in dental laboratory to make prosthesis, such as UCLA Plastic Cylinders. All abutments have been designed specifically to be compatible and to be used with each of the following implant systems and sizes (for engineering drawings please refer to Attachment GG), | IMPLANT COMPANIES | IMPLANT SYSTEMS | IMPLANT SIZE (mm) | |--------------------|--------------------------------|-----------------------------------------------------| | Nobel Biocare | NobelPerfect<br>Replace Select | 3.5, 4.3 & 5.0mm<br>3.5, 4.3, 5.0 & 6.0mm | | Straumann | ITI | 3.5mm Shoulder Diameter<br>Narrow Neck Solid Screw | | | ITI | 4.8mm Shoulder Diameter<br>Solid Screw | | | ITI | 6.5mm Shoulder Diameter<br>Wide Neck Solid Screw | | Dentsply/ Friadent | Frialit-2<br>XIVE | 3.4, 3.8, 4.5, 5.5 & 6.5mm<br>3.4, 3.8, 4.5 & 5.5mm | | 3i | Osscotite Certain | 4.0, 5.0 & 6.0mm | Over-The-Counter I Ise Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) ## (PLEASE DO NOT WRITE BELOW THIS I.INE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Suser Ruso CO34077 (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: _ Page 1 of ____________________________________________________________________________________________________________________________________________________________________