PERIO PROTECT TRAY

{0}------------------------------------------------ K031809 510(k) Summary for # Perio Protect Tray #### 1. DATE PREPARED January 14, 2004 #### 2. SPONSOR INFORMATION #### Main Office Perio Protect LLC 3929 Bayless Avenue St. Louis, MO 63125 Mailing Address Perio Protect LLC 3929 Bayless Avenue St. Louis, MO 63125 Contact Person: Duane C. Keller, D.M.D. (314) 638-4190 (telephone) (314) 638-3900 (facsimile) Outside Regulatory Counsel Gray Cary Ware & Freidenrich દામ 1625 Massachusetts Ave., NW - Ste 300 Washington, DC 20036 (202) 238-7749 (telephone) (202) 238-7701 (facsimile) Contact Person: David L. Rosen, R.Ph., J.D. {1}------------------------------------------------ ## 3. DEVICE NAME Proprietary Name: Perio Protect Tray Common/Usual Name: Dental Tray Classification Name: Disposable Fluoride Tray (per 21 C.F.R § 872.6870 (2002)) ## 4. DEVICE DESCRIPTION AND INTENDED USE The Perio Protect Tray is a custom fit tray made from impressions of the patents mouth taken by a licensed dentist. The patient impressions are then sent to a specialized dental laboratory which makes a custom fit tray for the individual patient. The Perio Protect Tray is intended to be used to place solutions of the clinician's choice into gingival crevices or periodontal pockets. The design of the Perio Protect Tray permits placement of solutions deeper into the crevice/pocket than is possible with traditional fluoride trays. The choice of solution, the frequency of use, and the time the tray is to be in place are a part of the practice of dentistry, and are to be determined by the clinician. ## 5. PREDICATE DEVICE Hoyt Laboratories Disposable Fluoride Tray - K 811154 Such products are now Class I Exempt per 21 C.F.R § 872.6870 (2002) {2}------------------------------------------------ ## Substantial Equivalence Comparison | | Delivery of Oral Irrigation Materials | Indication for Use | Design | Materials | Anatomic<br>Sites | |--------------------------------------------------------|---------------------------------------|------------------------------|-----------|-------------|-------------------| | rio Protect Tray<br>Fluoride Tray<br>Hoyt Laboratories | Site specific | Irrigation / solutions | Custom | Elastomeric | Teeth / gingiva | | 11154 | General area specific | Topical fluoride application | Preformed | Foam | Teeth | #### 6. DEVICE TESTING ## PERFORMANCE DATA - A. Data demonstrating different solutions used in the clinician's practice of dentistry are delivered to the teeth and surrounding tissues by use of the Perio Protect Tray. Sodium Fluorescein dye was mixed in an aqueous solution and applied to the Perio Protect Tray with one drop of Peroxyl (hydrogen peroxide) gel. Sodium Fluorescein is a phosphorescent dye that can be illuminated under a black light. The patients wore the trays 10 – 15 minutes in the morning and evening for one day. The patients were examined 24 hours later and a black light was used to illuminate the region around the teeth. Sodium fluorescein dye was observed in the gingival sulcus. - B. The force necessary to remove the Perio Protect Tray was also tested. Trays were also placed in the patient's mouth. A gram gauge was used to remove the tray from the patient's mouth. Each of these tests was repeated 10 times and an average of the force necessary to remove the tray was computed. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows two drawings of teeth. The top drawing shows a set of teeth labeled 44. The bottom drawing shows a set of teeth labeled 32 and 34. . {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a person with outstretched arms, composed of three curved lines. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 2 3 2004 Perio Protect LLC C/O Dr. David L. Rosen Gray Cary Ware & Freidenrich LLP 1625 Massachusetts Avenue NW, Suite 300 Washington, D.C. 20036-2247 Re: K031809/S1 Trade/Device Name: Perio Protect Tray Regulation Number: 21 CFR 872.6870 Regulation Name: Disposable Flouride Tray Regulatory Class: I Product Code: KMT Dated: October 27, 2003 Received: October 30, 2003 Dear Dr. Rosen: 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. {5}------------------------------------------------ Page 2 - Dr. Rosen 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 (OS) 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 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 vours, Chis 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 {6}------------------------------------------------ K031809 ## 510(k) Number (if known): K031809 Device Name: Indications for Use: Trade Name: Perio Protect Tray The Perio Protect Tray is intended to be used to place solutions of the clinician's choice into gingival crevices or periodontal pockets. The design of the Perio Protect Tray permits placement of solutions deeper into the crevice/pocket than is possible with traditional fluoride trays. The choice of solution, the frequency of use, and the time the tray is to be in place are a part of the practice of dentistry, and are to be determined by the clinician. ## PLEASE DO NOT WRITE BELOW THIS LINE (Continue on Another Page If Needed) Concurrence of CDRH, Office of Evaluation (ODE) (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number K031809 Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use