CAVIOS CAVITY LINER

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a world map and the number 12111668. The world map is a simple outline of the continents. The number is written in a handwritten style. The number is to the right of the world map. ## EMERGO GEROUP AUG 1 9 2011 ### Section 005 - Traditional 510(k) Summary As required in 21CFR 807.92, we hereby submit this 510(k) Summary: ### 510(k) owners name, address, phone, fax, contact person & prep date The 510(k) owner is NeoDental Chemical Products Co., Ltd. 3-1-3 Hiroo, Shibuyaku, Tokyo, Japan 150. Phone - 3 (3400) 3768, Fax - 3 (3499) 0613. The contact person is Mr. Nobuki Ishikawa, Treasurer, NeoDental International, Inc. 510(k) preparation date – 05 May 2011 ### Name of the device, trade name, proprietary name, and classification name Trade name: Cavios Cavity Liner Common name: Cavity Liner Classification name: Calcium hydroxide cavity liner (21 CFR 872.3250, Product Code EJK). ### Predicate Device: The legally marketed predicate for the Cavios® Cavity Liner is UltraBlend Plus Calcium Hydroxide Dentin Liner and Protective Base (K970113). ### Device Description: NeoDental Chemical Products, Inc, (NeoDental) wishes to submit their Cavios® Cavity Liner Device Material for 510(k) clearance. Cavios®, (shown in Figure 1) is a light cured single-component yellow-white paste for use as a dentin liner and base. The product is preloaded into syringes and expressed via the syringe plunger through single-use disposable tips. Following the application, Cavios® is cured (polymerized) with a light source (approximately 470 nm). Following polymerization, the restorative materials, amalgam, etc., may be placed. {1}------------------------------------------------ Image /page/1/Figure/0 description: This image shows a world map. The map is a simple outline, with the continents and major landmasses clearly visible. The map appears to be a simplified representation of the world, focusing on the shapes of the continents rather than specific details. # EMERGO GROUP Image /page/1/Figure/2 description: The image shows a product called "Cavios". The product is in a box with the name "Cavios" printed on it. There is also a tool with several attachments next to the box. The figure is labeled "Figure 1". Cavios® is packaged as a multiple use syringe, with new tips being attached for each patient. The syringe can be used until empty. The syringe is kept capped between uses and is fitted with a new tip just prior to use. The syringe is cleaned with an alcohol wipe before and after use. ### Indication for Use: Cavios® Cavity Liner is to be applied to the interior of a prepared cavity prior to the insertion of restorative materials. Cavity Liner is indicated for use in the general dental population. ### Intended Use: Cavios® Cavity Liner is a yellow-white, single-component, light cured, material for dentin liner and base. Cavios® is easily expressed through the plunger type syringe with single use disposable tips. Cavios is intended for the general dental patient population and can be delivered directly into the prepared cavity. The syringe application directly into the cavity. The Cavios material provides excellent radiopacity. The Intended Use information from the predicate product is equivalent and is reproduced below: Ultradent Products, Inc's "UltraBlend Plus" calcium hydroxide dentin liner and protective base" is indicated as a cavity liner and/or base material before placing either composite or amalgam. It is also used for pulp capping and small direct exposures without hyperemic bleeding. UltraBlend Plus may also be used as an opaque when amalgam has "tattooed" dentin and an esthetic restoration is being placed or when performing a crown repair where the metal is showing. As is documented in the comparison of Indications For Use, the Cavios® and Ultra-Blend Plus dentin liner and base are indicated for the same use, share the same clinical indication, clinical setting, target population, anatomical sites, intended use, prescription requirement, storage conditions and method of application. ### Technological characteristics - Cavios versus the predicate device {2}------------------------------------------------ Image /page/2/Picture/0 description: This image shows a world map with the continents outlined in black. The map includes North and South America, Europe, Africa, Asia, and Australia. The map appears to be a simple outline, without any additional details such as country borders or geographical features. # EMERGO GROUP A technical comparison of the subject device to the predicate device is detailed in the Substantial Equivalence discussion below. Cavios was designed, tested and compared to Ultra-Blend plus (see the comparison table below). Both Cavios and Ultra-Blend utilize a single-component material that is photo-polymerized to form a liner for subsequent placing of dental restorations. The primary difference between the subject device and the predicate is a minor difference in the filler material. Both products utilize urethane dimethacrylate as the photo-polymerizing base. Cavios employs a-Tricalcium phosphate whereby Ultra-Blend plus uses calcium hydroxyapetite as fillers. Both materials are mixed to maintain the properties of the paste and filling material. Both products utilize barium sulfate to provide radio opacity. The Cavios® Cavity Liner has been evaluated according to the recognized consensus standards and other testing (see sections 15 and 18) and was found to conform to all requirements. Test data is further discussed in the respective sections (biocompatibility and bench testing) ### Non clinical test data: A number of testing standards were utilized to evaluate Cavios (see Sections 15 and 18). Per ISO 10993-1, Annex A, Cavios can be categorized as follows: | Medical device categorization by: | | Biological effect for consideration | | | |-----------------------------------|------------------|-------------------------------------|------------------------------------------------------------------------|--| | Nature of body<br>contact | Category | External<br>Communicating<br>Device | Cytotoxicity<br>Sensitization<br>Irritation | | | | Contact | Tissue/bone/dentin | System Toxicity<br>Subchronic Toxicity<br>Genotoxicity<br>Implantation | | | | Contact duration | | C - Permanent (> 30<br>days) | | Urethane resin (UDMA), the main ingredient of Cavios has been widely used in dental restorative materials as a "composite resin". Alpha tricalcium phosphate and barium {3}------------------------------------------------ Image /page/3/Picture/0 description: This image shows a world map with the continents outlined. The map is a simple line drawing, with no colors or shading. The continents are all roughly in their correct positions, but the details of the coastlines are not very accurate. The map appears to be a simplified representation of the world, possibly intended for educational purposes. · Image /page/3/Picture/1 description: The image shows the text "EMERGO GROUP" in a simple, sans-serif font. The word "EMERGO" is followed by a circular logo with three curved lines inside. The word "GROUP" is placed after the logo, completing the company name. sulfate, ingredients of Cavios, have been widely used in filling materials as filler or radiopaque materials and are free of harmful substances. ISO 10993-1 presents a schema for deciding whether biocompatibility evaluation is required. Is there either direct or indirect contact? YES Is the material the same as in a commercially available device? YES YES Does the device have the same chemical composition as these devices? Are the manufacturing and sterilization processes the same? YES Is the contact to the body the same? YES Given this schema, there is no need to select biological tests. Nonetheless, we have obtained selected ISO 10993 test results for the Cavios product as follows. {4}------------------------------------------------ Image /page/4/Picture/0 description: This image shows a world map with the continents and islands outlined in black. The map appears to be a simple line drawing, with no shading or other details. The continents of North America, South America, Africa, Europe, Asia, and Australia are all visible. The map is centered on the Atlantic Ocean, with the Americas on the left and Europe and Africa on the right. ## EMERGO GROUP ### Table of biocompatibility tests conducted | Biological Test | Date & Lab | Method | Result | |--------------------------------------------------|----------------------|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Genotoxicity<br>ISO 10993-3 | 9/16/2002<br>Covance | Bacterial strains<br>(TA98, TA100,<br>TA1535, WP2uvrA),<br>S9+ S9 methods | Negative | | Hemolysis | 10/7/2002<br>Covance | Hemolysis in rabbit<br>whole blood assay | Cavios was tested for<br>Hemolysis both<br>directly and as<br>extracts. Test article<br>induced 0.1% to<br>2.8% hemolysis.<br>Cavios is considered<br>negative in this<br>assay. | | Cytotoxicity<br>ISO 7405 6.2/6.3,<br>ISO 10993-5 | 9/18/2002<br>Covance | Agar Overlay | Not cytotoxic to<br>cultured L929<br>mouse fibroblast<br>cells after a 24-hour<br>exposure. | | Sensitization<br>ISO 10993-10 | 9/12/2002<br>Covance | Guinea Pig<br>Maximization | Possible mild<br>sensitizer<br>(sensitization rate:<br>24 hr – 20%)<br>48 hr - 20% | We did not conduct testing for system toxicity, subchronic toxicity, irritation and implantation. The results above in addition to the long and widespread use of these compounds, suggests that there are no biocompatibility issues. A total of 93,000 Cavios units have shipped since 2004; there have been no incidents or adverse reports since 2005. Cavios also carries a CE Mark and was recently re-evaluated in October of 2010. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a world map with the continents and islands outlined in black. The map appears to be a simplified representation of the world, with less detail than a typical map. The continents of North America, South America, Europe, Africa, Asia, and Australia are all visible. . # EMERGO G GROUP ISO 4049:2000 Polymer-based restorative and luting materials: - Depth of Cure 1.4mm ● - Flexural Strength 59.9 Mpa - Water Sorption33. µg/mm3 . Solubility -0.8 µg/mm3 . End of 510(k) Summary Section . · {6}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 NeoDental Chemical Products Co., Ltd. C/O Mr. Robert Seiple EMERGO Group, Inc. 611 West 5th Street, Third Floor Austin, TX 78701 AUG 1 9 2011 Re: K111668 Trade/Device Name: Cavios® Cavity Liner Regulation Number: 21 CFR 872.3250 Regulation Name: Calcium Hydroxide Cavity Liner Regulatory Class: II Product Code: EJK Dated: June 13, 2011 Received: June 14, 2011 .Dear Mr. Seiple: 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. {7}------------------------------------------------ Page 2 - Mr. Seiple 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 (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. 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/ucm1115809.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, Wh for. 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 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows a world map with the continents outlined. The continents of North America, South America, Europe, Africa, Asia, and Australia are all visible. The map appears to be a simple outline, with no additional details such as country borders or major cities. ## EMERGO GEROUP ### Section 004 - Indication for Use ## INDICATIONS FOR USE STATEMENT 510(k) Number (if known): K111668 Cavios® Cavity Liner Device Name: Indications for Use: Cavios® Cavity Liner is to be applied to the interior of a prepared cavity prior to the insertion of restorative materials. Cavity Liner is indicated for use in the general dental population. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | (Division Sign-Off) | | |----------------------------------------------|---------| | Division of Anesthesiology, General Hospital | | | Infection Control, Dental Devices | | | 510(k) Number: | K111668 | Page 1 of 1 EMERGO GROUP INC. 611 West 5 Street Third Floor | Austin, Texas 78701 | USA | Telephone: +1 512 327 9997