GLUSITE, MODEL GLU002

{0}------------------------------------------------ K 013446. ## 510(k) SUMMARY The Summary of Safety and Effectiveness on the GlaSite reflects data available and experiences in the time the submission was The Summary of Saley and Elfectivelies on the Glickle reliects data Prairies and or test may requires in the closes of the conclusions or recommendations set forth. | Applicant | Don Blacklock<br>GluStitch, Inc.<br>7188 Progress Way, #307<br>Delta, BC., V4G 1M6 | DEC 2 0 2001 | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Telephone | (800) 667-2130 | | | Facsimile | (877) 450-4000 | | | Date | October 15, 2001 | | | Name | GluSite | | | Classification | Dental Cement, 21 CFR 872.3275 | | | Predicate: | CLOSURE Medical Corporation's Octyldent®, K980159 – market<br>clearance date, April 9, 1998 | | | Description | GluSite (2-octyl cynoacrylate) is a clear colorless, free-flowing liquid<br>monomer packaged in a glass multiple-use vials. Upon contact with weak<br>bases, GluSite polymerizes to form a strong adhesive bond. Depending on<br>the availability of moisture, this could take up to one minute. | | | Intended Use | GluSite is indicated for use as dental cement for bonding dental materials<br>such as crowns, caps, and pins, or temporarily attaching a fiber to the<br>surface of the tooth in a procedure to treat periodontal disease. | | | Contraindication: | • GluSite is contraindicated for use in patients with hypersensitivity to<br>the adhesive.<br>• GluSite must not come in contact with the conjunctival sac since<br>conglutination may occur. | | | Caution: | • Federal law (U.S.A.) restricts this device to sale by or on the order of a<br>physician. | | | Technological<br>Characteristics | The intended use of the GluStitch, Inc.'s GluSite and CLOSURE Medical<br>Corporation's Octyldent® are equivalent. The chemical composition,<br>octyl cyanoacrylate are equivalent, and test results demonstrates that the<br>two devices are equivalent in performance. | | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 2 0 2001 Mr. Donald Blacklock President GluStitch, Incorporated #307 7188 Process Way Delta, British Columbia, CANADA Re: K013446 Trade/Device Name: GluSite Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: October 15, 2001 Received: October 15, 2001 Dear Mr. Blacklock: 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 {2}------------------------------------------------ Page 2 - Mr. Blacklock of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I oderal buter and systements, including, but not limited to: registration You must comply with an the Free Progant CPT CFR Part 801); good manufacturing practice allu listing (21 OF R Pat 007), acclines (QS) regulation (21 CFR Part 820); and if requirences as set form in the qualify is a 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 I his letter will anow you to ocgin maneting your and equivalence of your device to 310(k) promance noticate 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 If you desire specific ac not 70. Jour for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and Office of Collightance at (e office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under nother (11 OF CF CF CF CF CF CF Cr of Small Manufacturers, International and the Act may of obtained install-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health ## Enclosure {3}------------------------------------------------ Page 1 / 008 of 1 / 008 | 510(k) Number (if known): | K013446 | |---------------------------|---------| | Device Name: | GluSite | Indications For Use: GluSite is indicated for use as dental cement for bonding dental materials such as the tooth Grusite is indicated for as as demail concerners a fiber to the surface of the tooth in a procedure to treat periodontal disease. (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) (Division Sign-Off) 510(k) Number _ and General Hospital Dev user Ninger Division Sign-only Division of Dental, Infection Control, OR Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________ 1 / 008 (Optional Format 1-2-96)