RETRIEVE IMPLANT CEMENT

{0}------------------------------------------------ ## 510(k) SUMMARY JUN 1 0 2010 Submitter: Parkell, Inc. 300 Executive Drive Edgewood, NY 11717 TEL: 631-249-1134 FAX: 631-249-1242 Contact: Daniel R. Schechter, Esq. General Counsel Parkell, Inc. 300 Executive Drive Edgewood, NY 11717 13 APRIL 2010 Submission Date: Trade Name: RETRIEVE Common Name: Dental Cement Dental Cement Classification Name: Classification Product Code: EMA PREMIER IMPLANT CEMENT (K033309), IMPROV TEMPORARY Predicate Devices: CEMENT (K982400), TEMPORARY RESIN CEMENT (K031212) RETRIEVE is an acrylate- and methacrylate-based resin cement for Device Description: semi-permanent cementation of porcelain, ceramic, resin and metalbased dental prostheses to dental implants. The cement is not considered fully "permanent," and is therefore substantially equivalent to temporary cements, because its bond strength is high enough to maintain the prosthesis in place during normal wear, but low enough to allow for removal by a dental professional for maintenance, replacement, and/or hygienic cleaning. Implant Cement is a resin-based, self-curing, RETRIEVE dual-Intended Use: component dental cement. It is intended for mid- to long-term (semipermanent) cementation of porcelain, ceramic, resin, and metal-based dental prostheses to dental implants, while allowing retrieval of the prostheses, if necessary. RETRIEVE can also be used as a temporary filling material. RETRIEVE dental implant cement is a two-part cement and is typically Tech. Characteristics: supplied in a double-barrel, auto-mix syringe. The cement system does not require acid etching of tooth surfaces, and self-cures. {1}------------------------------------------------ ### Substantial Equivalence: Parkell's RETRIEVE dental cement for implants has similar indications, principles of operation, and technological characteristics as the predicate devices. The minor differences in the device do not raise any new questions of safety or effectiveness. Thus, RETRIEVE is substantially equivalent to its predicate devices. A brief comparison to Premier Implant Cement, as an example, is as follows: | Property | RETRIEVE | Premier Implant Cement | |-------------------------------------------------------------|---------------------|------------------------| | Type of cement | Resin cement | Resin cement | | Delivery System | Dual-barrel syringe | Dual-barrel syringe | | Self-Cure | Yes | Yes | | Working Time | 2 minutes | 2-2.5 min. gel phase | | Setting Time | 5 minutes | 5 minutes | | Average bond strength | 5.5 MPa | 4.7 MPa | | Average bond strength of<br>Titanium post to metal crown | 2.7 MPa | 1.7MPa | | Average bond strength of Zirconia<br>post to Zirconia crown | 2.0 MPa | 1.3 MPa | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine and health. The caduceus is placed to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Daniel R. Schechter Vice President, Regulatory Affairs Parkell. Incorporated 300 Executive Drive Edgewood, New York 11717 JUN 1 0 2010 Re: K101044 Trade/Device Name: RETRIEVE Implant Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: April 13, 2010 Received: April 14, 2010 Dear Mr. Schechter: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Schechter 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, fir Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ K101044 # Indications for Use 510(k) Number (if known): Device Name: RETRIEVE Implant Cement ### Indications for Use: RETRIEVE Implant Cement is a resin-based, self-curing, dual-component dental cement. It is intended for mid- to long-term (semi-permanent) cementation of porcelain, ceramic, resin, and metal-based dental prostheses to dental implants, while allowing retrieval of the prostheses, if necessary. Retrieve can also be used as a temporary filling material. Prescription Use X (21 CFR Part 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR Part 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation ( (Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices K 101044 510(k) Number: .Page 1 of