SIMPACT IMPLANT SYSTEM

{0}------------------------------------------------ K081226 ## SEP 1 2 2008 # 510(k) Summary of Safety and Effectiveness: ### SIMPACT Implant System | Submitter: | SIMPACT LLC<br>300 Interpace Parkway<br>Suite 410<br>Parsippany, NJ 07054 | |-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Alan Lombardo<br>President<br>Phone: 973-698-1128<br>Email: aappolloria@hotmail.com | | Date Prepared | September 2, 2008 | | Trade Name | SIMPACT Endosseous Dental Implant | | Classification Name<br>and Number | Endosseous dental implant and abutment<br>21 CFR 872.3630<br>21 CFR 872.3640 | | Product Code | DZE, NHA | | Predicate Devices | Lifecore Biomedical K051614<br>Friadent K041509<br>Ankylos K012681<br>CAMLOG K00099 | | Device Description | The SIMPACT Endosseous Dental Implant System. | | Intended Use | Simpact Dental Implant System is intended for use in partially<br>or fully edentulous mandibles and maxillae, in support of single<br>or multiple-unit restorations including; cement retained terminal<br>or intermediate abutment support for fixed bridgework. | | | The Simpact implant is a threaded/tapered internal connection | | | implant. The Simpact implant is intended for immediate | | | placement, where immediate implant placement is defined by | | | the International Congress of Oral Implantologists (ICOI) as the | | | placement of an implant at the time of tooth extraction, into the | | | extraction socket. | | | | | | The Simpact implant is intended for immediate | | | provisional loading when primary stability and proper occlusion | | | are present. Immediate Provisionalization is defined by the | | | International Congress of Oral Implantologists (ICOI) as a | | | clinical protocol for the placement of an interim prosthesis | | | with occlusal contact with the opposing dentition, at the same | | | clinical visit of implant placement. The Simpact implant can be | | | restored with a temporary prosthesis in single tooth and multiple | | | tooth applications. | | | | | Statement of | The SIMPACT implant system and its predicate devices have | | Technological | the same indications for use have a similar design and are made | | Comparison | of the similar materials. | | Conclusion | The SIMPACT implant system is substantially equivalent to its | | | predicate devices. This conclusion is based upon the fact that | | | this device is substantially equivalent in terms of indications for | | | use, materials, design and principles of operation. | {1}------------------------------------------------ : {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized depiction of an eagle or bird-like figure. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 1 2 2008 Mr. Alan Lombardo Simpact, LLC 300 Interpace Parkway Building C 3rd Floor Parsippany, New Jerscy 07054 Rc: K081226 Trade/Device Name: SIMPACT Endosseous Dental Implant Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: September 2, 2008 Received: September 3, 2008 Dear Mr. Lombardo: 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 - Mr. Lombardo 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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. Khamails Ludi-r for u Chiu S. Lin, Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ### Indications for Use #### 510(k) Number K081226 SIMPACT Endosseous Dental Implant Indications for Use: Device Name: Simpact Dental Implant System is intended for use in partially or fully edentulous mandibles and maxillae; in support of single or multiple-unit restorations including; cement retained terminal or intermediate abutment support for fixed bridgework. The Simpact implant is a threaded/tapered internal connection implant. The Simpact implant is intended for immediate placement, where immediate implant placement is defined by the International Congress of Oral Implantologists (ICOI) as the placement of an implant at the time of tooth extraction, into the extraction socket. The Simpact implant is intended for immediate provisional loading when primary stability and proper occlusion are present. Immediate Provisionalization is defined by the International Congress of Oral Implantologists (ICOI) as a clinical protocol for the placement of an interim prosthesis with occlusal contact with the opposing dentition, at the same clinical visit of implant placement. The Simpact implant can be restored with a temporary prosthesis in single tooth and multiple tooth applications. Prescription Use X AND/OR Over-the-counter (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Runpe (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: LCDS12076 Revised September 2, 2008