BIO-C REPAIR

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Angelus Industria de Produtos Odontologicos S/A Juliana Norder International Regulatory Affairs Analyst Rua Waldir Landgraf, 101 Londrina, 86.031-218 Br ### Re: K180185 Trade/Device Name: BIO-C Repair Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: January 12, 2018 Received: January 23, 2018 ### Dear Juliana Norder: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 August 31, 2018 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Mary S. Runner -S For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) Device Name BIO-C REPAIR Indications for Use (Describe) - 1. Furcation or root perforation treatment via canal; - 2. Furcation or root perforation treatment via surgical; - 3. Internal reabsorption treatment via canal or surgical; - 4. External reabsorption treatment; - 5. Retrofilling in parendodontic surgery; - 6. Direct and indirect pulp capping; 7. Apexification; 8. Apexogenesis and Pulpotomy. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (7/17) Page 1 of 1 EF PSC Publishing Services (301) 443-6740 Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ ## 510(k) Summary ### Angelus Indústria de Produtos Odontológicos S/A ### BIO-C REPAIR August 31, 2018 ## ADMINISTRATIVE INFORMATION | Manufacturer Name: | Angelus Indústria de Produtos Odontológicos S/A | |--------------------|-------------------------------------------------| | | Rua Waldir Landgraf, 101 | | | Londrina, PR 86031-218 Brazil | | | Telephone: +55 (43) 2101-3200 | | | Fax: +55 (43) 2101-3201 | | Official Contact: | Juliana Norder | | | International Regulatory Affairs Analyst | juliana.norder@angelus.ind.br ## DEVICE NAME AND CLASSIFICATION | Trade/Proprietary Name: | BIO-C REPAIR | |-----------------------------|------------------------------------------------------------------------| | Common Name: | Root Canal Filling Resin | | Classification Regulation: | 21 CFR 872-3820, Class II | | Product Code: | KIF | | Classification Panel: | Dental Products Panel | | Reviewing Branch: | Dental Devices Branch | | Primary Predicate Device: | K082943 iRoot BP (Innovative BioCeramix Inc.) | | Secondary Reference Device: | K172701 BIO-C SEALER (Angelus Indústria de Produtos odontológicos S.A) | {4}------------------------------------------------ ### DEVICE DESCRIPTION BIO-C REPAIR is a ready-to-use bioceramic MTA-based paste developed for permanent root canal repair and surgical applications. The product is a single paste provided in a syringe with disposable tips to be applied to the affected area of the root canal system. BIO-C REPAIR is an insoluble and radiopaque material which requires the presence of water to set and harden. ### PRODUCT PRESENTATION | Reference | Product Description | Package Contents | |-----------|---------------------|--------------------------------------------------------------------------| | 3863 | BIO-C REPAIR | • 4 preloaded syringes with 0.5g each<br>• 20 disposable intracanal tips | #### INTENDED USE Reparative cement for endodontic complications. ### INDICATIONS FOR USE - 1. Furcation or root perforation treatment via canal; - 2. Furcation or root perforation treatment via surgical; - 3. Internal reabsorption treatment via canal or surgical; - 4. External reabsorption treatment; - 5. Retrofilling in parendodontic surgery; - 6. Direct and indirect pulp capping; - 7. Apexification; - 8. Apexogenesis and Pulpotomy. ### EQUIVALENCE TO MARKETED DEVICE Angelus Indústria de Produtos Odontológicos S/A demonstrated that, for the purposes of FDA's regulation of medical devices, BIO-C REPAIR is substantially equivalent in indications and design principles to the following predicate device: INNOVATIVE BIOCERAMIX INC., iRoot BP cleared under K082943 {5}------------------------------------------------ The subject device and the predicate device have the same intended use and same technological characteristics and are made of similar materials. They encompass the same range of physical and chemical properties. The subject and predicate devices are packaged in similar materials and use similar methods of application. Any differences in specific components do not raise new issues of safety or efficacy. Even though BIO-C REPAIR's main chemical composition is based on iRoot BP, as mentioned above, the additional chemical components in BIO-C REPAIR's composition and the delivery system were found in the following predicate device: ANGELUS INDÚSTRIA DE PRODUTOS ODONTOLÓGICOS S/A, BIO-C SEALER cleared under K172701. #### COMPARISON TO THE CLEARED DEVICES BIO-C REPAIR and iRoot BP are designated for the equivalent dental applications, have comparable chemical and physical properties and performance specifications. The secondary reference device, BIO-C SEALER, contains specific chemical components that are found in BIO-C REPAIR; providing evidence that these chemical components are safe and effective for medical device use and therefore does not affect the substantial equivalence. Furthermore, BIO-C REPAIR and BIO-C SEALER (K172701) have identical delivery systems (syringe and disposable intracanal tips). The similarities and differences of BIO-C REPAIR and the predicates are discussed below: - > BIO-C REPAIR, iRoot BP and BIO-C SEALER are mainly composed of tricalcium silicate and dicalcium silicate. These inqredients are responsible for physical and biological properties of both products. - > Zirconium oxide is present in BIO-C REPAIR, iRoot BP and BIO-C SEALER compositions. This ingredient is responsible for the radiopacity of the products. - > BIO-C REPAIR and BIO-C SEALER uses calcium oxide as Ca²+ an OH sources while iRoot BP relies only on calcium silicates to provide calcium and hydroxyl ions. - > BIO-C REPAIR and BIO-C SEALER share the same dispersing agent, while iRoot BP does not discloses its carrier. - く iRoot BP also contains calcium phosphate monobasic and tantalum pentoxide, unlike BIO-C REPAIR and BIO-C SEALER. - BIO-C REPAIR, iRoot BP and BIO-C SEALER share the same Delivery System (syringe and > disposable intracanal tips). {6}------------------------------------------------ Therefore, it is concluded that BIO-C REPAIR is substantially equivalent to the predicate devices. The table below summarizes the main similarities of BIO-C REPAIR and the predicate devices: | Element | Proposed Device | Predicate Device<br>(K082943) | Reference<br>Device | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | (K172701) | | Trade Name | BIO-C REPAIR | iRoot BP | BIO-C SEALER | | Manufacturer | ANGELUS INDÚSTRIA DE<br>PRODUTOS<br>ODONTOLÓGICOS S/A | INNOVATIVE BIOCERAMIX<br>INC. | ANGELUS INDÚSTRIA DE<br>PRODUTOS<br>ODONTOLÓGICOS S/A | | Device Description | BIO-C REPAIR is a ready-<br>to-use bioceramic<br>reparative cement. | iRoot BP Injectable Root<br>Canal Repair Filling<br>Material is a convenient<br>ready-to-use white<br>hydraulic premixed<br>injectable paste developed<br>for permanent root canal<br>repair and filling<br>applications. | BIO-C SEALER is a ready-<br>to-use injectable<br>endodontic bioceramic<br>Sealer, suitable for<br>obturation of root canals. | | Common Name | Root Canal Filling Resin | Root Canal Filling Resin | Root Canal Filling Resin | | Class | Class II | Class II | Class II | | Product Code | KIF | KIF | KIF | | Composition | Calcium silicates<br>Calcium oxide<br>Zirconium oxide<br>Silicon oxide<br>Iron oxide<br>Dispersing agent | Tricalcium silicate<br>Dicalcium silicate<br>Calcium phosphate<br>monobasic<br>Zirconium oxide<br>Tantalum Pentoxide<br>Filler agents | Calcium silicates<br>Calcium oxide<br>Zirconium oxide<br>Silicon oxide<br>Iron oxide<br>Dispersing agent | | Principle of<br>operation | BIO-C REPAIR is an<br>insoluble and radiopaque<br>root repair material which<br>requires the presence of<br>water to set and harden.<br>Calcium hydroxide is<br>produced due to the<br>hydration reaction of the<br>calcium silicates and<br>calcium oxide increasing<br>the pH of the medium. | iRoot BP is a ready-to-use<br>white hydraulic premixed<br>injectable paste developed<br>for permanent root canal<br>repair and filling<br>applications. iRoot<br>BP is an insoluble,<br>radiopaque and aluminum-<br>free material based on a<br>calcium silicate<br>composition, which<br>requires the presence of<br>water to set and harden.<br>iRoot BP does not shrink<br>during setting and is<br>packaged in a preloaded<br>syringe and is supplied<br>with disposable tips. | BIO-C SEALER is an<br>insoluble and radiopaque<br>root canal sealer which<br>requires the presence of<br>water to set and harden.<br>Calcium hydroxide is<br>produced due to the<br>hydration reaction of the<br>calcium silicates and<br>calcium oxide increasing<br>the pH of the medium. | | Indications for use | 1. Furcation or root<br>perforation treatment via<br>canal;<br>2. Furcation or root<br>perforation treatment via<br>surgical;<br>3. Internal reabsorption<br>treatment via canal or<br>surgical;<br>4. External reabsorption<br>treatment; | Repair of Root Perforation<br>Repair of Root Resorption<br>Root End Filling<br>Apexification<br>Pulp Capping | Sealing the root canal of<br>permanent teeth;<br>Internal reabsorption<br>treatment. | | Delivery form | Single paste | Single paste | Single paste | | Design | Syringe<br>Disposable Intra Canal tips | Syringe<br>Disposable Intra Canal tips | Syringe<br>Disposable Intra Canal tips | | Nature of contact | Category: External<br>communicating device<br>Contact: Tissue, bone and<br>dentin<br>Contact Duration: C -<br>Permanent (>30 days) | Category: External<br>communicating device<br>Contact: Tissue, bone and<br>dentin<br>Contact Duration: C -<br>Permanent (>30 days) | Category: External<br>communicating device<br>Contact: Tissue, bone and<br>dentin<br>Contact Duration: C -<br>Permanent (>30 days) | | Sterile | Non-sterile | Non-sterile | Non-sterile | | pH | 12.5 | > 12 | 12.5 | | Setting time | 90 - 120 minutes | ~ 2 hours | 120-240 minutes | | Radiopacity | $\ge$ 7 mm Al | ~ 7 mm Al | $\ge$ 7 mm Al | | Biocompatibility | Biocompatible | Biocompatible | Biocompatible | | Contraindications | Do not use it in patients<br>that report sensitivity to<br>the components of the<br>formula. | Do not use in patients<br>with a known allergy to<br>any of the product's<br>ingredients. | Do not use it in patients<br>that report sensitivity to<br>the components of the<br>formula. | | Shelf Life | 2 years | 2 years | 2 years | | Environment of use | Prescription / Hospital | Prescription / Hospital | Prescription / Hospital | | Intended<br>environment | Dental offices | Dental offices | Dental offices | | Intended users | Dental practitioners | Dental practitioners | Dental practitioners | | Intended patient<br>population | Patients who require<br>endodontic treatment. | Patients who require<br>endodontic treatment. | Patients who require<br>endodontic treatment. | | Storage | Keep the product in a dry<br>and ventilated place<br>between 15 and 30°C and<br>with relative humidity<br>below 60%.<br>Do not store it in a<br>refrigerator.<br>Do not store the product<br>near ammonia,<br>ammonium nitrate and<br>products containing<br>chlorine. Avoid using<br>disinfectant solutions that<br>contain any of these<br>ingredients. | - Keep tightly closed in its<br>sealed package and store<br>it at room temperature in<br>a dry area, to avoid<br>moisture contact, which<br>could induce the setting<br>process.<br>- Be certain to tightly<br>secure the lid of the jar<br>after each use.<br>- Use the syringe cap to<br>keep the syringe tightly<br>closed when not using the<br>material.<br>- Do not use excessive<br>force to apply the material<br>into the root canal, as this<br>may cause acute pain to | Keep the product in a dry<br>and ventilated place<br>between 15 and 30°C and<br>with relative humidity<br>below 60%.<br>Do not store it in a<br>refrigerator.<br>Do not store the product<br>near ammonia,<br>ammonium nitrate and<br>products containing<br>chlorine. Avoid using<br>disinfectant solutions that<br>contain any of these<br>ingredients. | {7}------------------------------------------------ {8}------------------------------------------------ #### PERFORMANCE DATA OR NON-CLINICAL EVIDENCE BIO-C REPAIR has undergone extensive bench testing to provide evidence that its physical-chemical properties are substantially equivalent to iRoot BP. The following bench tests were performed according to ISO 6876:2012 Dental root canal sealing materials: setting time, solubility and radiopacity. Both devices are provided non-sterile and have comparable setting time, pH and radiopacity. Although we did not find the solubility of the predicate, our product when subjected to solubility tests presented values in accordance with the established by the international standard. ### CONCLUSION BIO-C REPAIR and its predicate device are designated for equivalent dental applications and have comparable chemical and physical properties and performance specifications. Furthermore, BIO-C REPAIR and its predicate device have equivalent shelf life, packaging containers and delivery systems. Based on the information provided in the premarket notification, we can conclude that the subject device is substantially equivalent to the predicate device.