ENDOSEAL MTA

{0}------------------------------------------------ February 26, 2018 Maruchi Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc 800 Roosevelt STE 417 Irvine, California 92620 Re: K170175 Trade/Device Name: Endoseal MTA Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: January 17, 2018 Received: January 26, 2018 Dear Priscilla Chung: 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. 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 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); {1}------------------------------------------------ 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-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}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K170175 Device Name ENDOSEAL MTA Indications for Use (Describe) · Permanent obturation of the root canal following vital pulp-extirpation • Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------| | V D--------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | O -- TL- O- -- L--- II-- II-- IO4 OFF OOL O I---- | || | 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." {3}------------------------------------------------ # 510(k) Summary (K170175) This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date: ___01/17/2018_____ #### Applicant / Submitter: 1. MARUCHI 2-208, 42-10, Taejanggongdan-gil, Wonju-si, Gangwon-do, 26311, Republic of Korea Tel: +82-33-734-0330 Fax:+82-33-746-2804 #### 2. Submission Correspondent: Priscilla Chung LK Consulting Group USA, Inc. 800 Roosevelt STE 417 Irvine CA 92620 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com #### 3. Device: | Proprietary Name: | ENDOSEAL MTA | |------------------------------|---------------------------| | Common Name: | Root Filling Material | | Classification Name: | Root Canal Filling Resin | | Classification: | Class II, 21 CFR 872.3820 | | Classification Product Code: | KIF | #### 4. Predicate Device: ENDOSEAL (K133054) by MARUCHI MTA Fillapex (K113568) by Angelus Industria de Produtos Odontologicos IROOT SP (K080917) by Innovative BioCeramix Inc. {4}------------------------------------------------ #### 5. Device Description: ENDOSEAL MTA is an endodontic sealer based on MTA, providing a biocompatible and effective root canal filling. It is premixed and pre-loaded in a syringe, which allows a complete filling of the entire root canal including accessory and lateral canals. The product is eugenol-free and will not impede adhesion inside the root canal. #### 6. Indications for Use - Permanent obturation of the root canal following vital pulp-extirpation - · Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings. #### 7. Performance Data(Non-Clinical): The following properties were tested based on the referenced standard. All the test results met the preset test criteria. - = ISO 6876 Visual, Capacity, Packaging, Flow, Setting time, Film Thickness, Solubility and Radiopacity - = Shelf Life Test ISO 6876 (Visual, Packaging, Setting time, Solubility) - ISO 10993-5 Cytotoxicity - ISO 10993-10 Maximization test for delayed hypersensitivity (LLNA) - ISO 10993-11 Acute systemic toxicity - ISO 10993-6 Implantation - ISO 10993-3 AMES & Mammalian Erythrocyte Micronucleus {5}------------------------------------------------ #### 8. Substantial Equivalence | | Proposed Device | Predicate Device | Predicate Device | Predicate Device | Discuss/Justify the | |----------------|-------------------------|-------------------------|-------------------------|------------------------|---------------------| | | (K170175) | (K133054) | (K113568) | (K080917) | Differences | | Trade Name | ENDOSEAL MTA | ENDOSEAL | MTA Fillapex | IROOT SP | | | Device | ENDOSEAL MTA is | The raw materials of | MTA Fillapex is a | iRoot SP Root Canal | Equivalent | | Description | an endodontic sealer | the ENDOSEAL are | mineral trioxide | Sealer(IRoot SP) is | | | | based on MTA, | Natural Pure Cement, | aggregate(MTA) and | premixed ready-to-use | | | | providing a root canal | Zirconium dioxide, | resin root canal sealer | injectable white | | | | filling. It is premixed | and | used during | hydraulic cement | | | | and pre-loaded in a | Citric acid anhydrous. | endodontic treatment | paste developed for | | | | syringe, which allows | It is prepared as a | to permanently fill the | permanent root canal | | | | a complete filling of | mixture of powder | canal system | filling and sealing | | | | the entire root canal | and water, and it is | following | applications. iRoot SP | | | | including accessory | used in a putty | debridement and | is an insoluble. | | | | and lateral canals. | form which gradually | disinfection. It | radiopaque and | | | | | hardens in the oral | consists of two | aluminum-free | | | | | environment. | component pastes that | material based on a | | | | | | are combined in a dual | calcium silicate | | | | | | barrel syringe for ease | composition, which | | | | | | of dispensing and | requires the presence | | | | | | consistent dosage. | of water to set and | | | | | | | harden. iRoot SP is | | | | | | | packaged in a pre- | | | | | | | loaded syringe and is | | | | | | | supplied with | | | | | | | disposable Intra Canal | | | | | | | Tips. | | | Common Name | Root Filling Material | Root Filling Material | Root Filling Material | Root Filling Material | Equivalent | | Classification | Root Canal Filling | Root Canal Filling | Root Canal Filling | Root Canal Filling | Equivalent | | Name | Resin | Resin | Resin | Resin | | | Class | Class II | Class II | Class II | Class II | Equivalent | | Product Code | KIF | KIF | KIF | KIF | Equivalent | | Indications | ▪ Permanent | ■ Repair of perforation | MTA Fillapex is a | ▪ Permanent | Equivalent | | for Use | obturation of the root | ▪ Root canal filling | root canal sealer | obturation of the root | | {6}------------------------------------------------ | | canal following vital<br>pulp-extirpation<br>▪ Permanent<br>obturation of the root<br>canal following<br>removal of infected or<br>necrotic pulp and<br>placement of<br>intracanal dressings. | | intended for the<br>permanent sealing of<br>root canals and may<br>be used in<br>combination with root<br>canal obturation<br>materials. | canal following vital<br>pulp-extirpation<br>▪ Permanent<br>obturation of the root<br>canal following<br>removal of infected or<br>necrotic pulp and<br>placement of<br>intracanal dressings.<br>iRoot SP is suitable<br>for use in the single<br>cone and lateral<br>condensation<br>technique. | | |-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------| | Shelf Life | 2 years | 2 years | 2 years | | Equivalent | | Standards | ISO 6876 | ISO 6876 | ISO 6876 | ISO 6876 | Equivalent | | Basic Chemical<br>Composition | Natural pure cement<br>Zirconium dioxide<br>Bismuth trioxide<br>Bentonite Clay | Natural pure cement<br>Zirconium dioxide<br>Citric acid anhydrous | Dicalcium and<br>tricalcium silicate,<br>tricalcium aluminate,<br>calcium oxide, | Zirconium oxide<br>Calcium silicates<br>Calcium phosphate<br>monobasic | The main ingredients<br>are similar but some<br>other ingredients are<br>different. However, | | | n-Methyl-2-<br>Pyrrolidone<br>Hypromellose | | pentaerythritol<br>rosinate, n-ethyl-o,<br>p-toluenesulfonamide<br>salicylate resin,<br>bismuth oxide, fumed<br>silica, titanium<br>dioxide | Calcium hydroxide<br>Filler and thickening<br>agents | the biocompatibility<br>and the performance<br>test results supported<br>that the subject device<br>is substantially<br>equivalent to the<br>predicate devices. | | Liquid Formula | Premixed type | Mixing with distilled<br>water | Mixing through a dual<br>barrel syringe | Premixed type | Equivalent | | Packaging | Pre-loaded syringe | Vial | Dual barrel syringe | Pre-loaded syringe | Equivalent | | Sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Equivalent | {7}------------------------------------------------ ENDOSEAL MTA has the same indications for use and the principle of operations as the predicate devices. It has similar physical and biocompatible properties, and demonstrates comparable performance specifications to the predicate devices. In addition, ENDOSEAL MTA has a comparable delivery system to IROOT SP. Endoseal MTA and all of the predicate devices are equivalent as they all release calcium silicate oxide and calcium hydroxide by undergoing setting reactions when water reacts with calcium oxide. The reaction results in near identical composition of products after setting, as all of liquid components would have expelled during the setting reaction. Hence, all of the products resulted in similar test results including the cytotoxicity test. The material compositions might slightly different from the predicate devices, however, despite of this difference, the test results of biocompatibility and performance tests show that the subject device is substantially equivalent to the predicate devices. The bench and biocompatibility testing performed demonstrates that any differences in their technological characteristics do not raise any new questions as to safety and effectiveness. Therefore, it is concluded that ENDOSEAL MTA is substantially equivalent to the predicate devices. #### 9. Conclusion: Based on the testing results, MARUCHI concludes that the ENDOSEAL MTA is substantially equivalent to the predicate devices.