Dia-Proseal

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 26, 2019 Diadent Group International Myung Sub Kim Quality Assurance Manager 16. Osongsaengmyeong 4-ro. Osong-eup, Heungdeok-gu Cheongji-si, 28161 KOREA Re: K182009 Trade/Device Name: DIA-PROSEAL Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: August 30, 2019 Received: August 30, 2019 Dear Myung Sub Kim: 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. for Srinivas Nandkumar, PhD Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality 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) K182009 Device Name DIA-PROSEAL Indications for Use (Describe) DIA-PROSEAL is used for permanent sealing of root canals in secondary dentition with gutta percha points. 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. 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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ # 510(k) Summary ### 5.0 Application Information | Date Prepared: | 26th Sep, 2019 | |------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------| | Company Name and<br>Address: | DiaDent Group International<br>16, Osongsaengmyeong 4-ro, Osong-eup, Heundeok-gu, Cheongju-<br>si, Chungcheongbuk-do, 28161, Republic of Korea | | Contact Person: | Myung Sub Kim<br>Quality Assurance Manager<br>Phone: +82-43-266-2315<br>FAX: +82-43-235-2315<br>Email: diadent32@diadent.co.kr | ### 5.1 Device Information | Device Type: | Root Canal Filling Resin | |-------------------------|--------------------------| | Regulation Description: | Root Canal Filling Resin | | Review Panel: | Dental | | Regulation Number: | 21 CFR 872.3820 | | Product Code: | KIF | | Device Class: | II | | Device Name: | DIA-PROSEAL | #### 5.2 Predicate Devices The legally marketed devices to which substantial equivalence is being claimed are: | 510(k) Number: | K960548 | |--------------------|---------------------------| | Applicant: | Dentsply International | | Device Name: | AH Plus Root Canal Sealer | | Regulation Number: | 21 CFR 872.3820 | | Product Code: | KIF | | Device Class: | II | #### 5.3 Device Description DIA-PROSEAL Root Canal Sealer is two-component systems that react via an epoxide/amine chemical reaction to case setting. #### 5.4 Intended Use/Indications for Use - DIA-PROSEAL is used for permanent sealing of root canals in secondary dentition with gutta percha points. {4}------------------------------------------------ # 5.5 Technological Characteristics This device compares to the legally marketed devices as follows: | | Subject Device | Primary Predicate Device | Discuss | |-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product name | Dia-ProSeal | AH Plus | | | Manufacturer | DiaDent Group International | Dentsply | | | 510K Number | K182009 | K960548 | | | Product Code | KIF | KIF | | | Intended use | DIA-PROSEAL is used for permanent<br>sealing of root canals in secondary<br>dentition with gutta percha points. | AH Plus Root Canal Sealer is used for<br>permanent sealing of root canals<br>following established endodontic<br>procedures. | Equivalent | | Image | Image: Dia-Proseal product packaging | Image: AH Plus product packaging | | | Main<br>ingredient | Base<br>Bisphenol A epoxy resin<br>Bisphenol F epoxy resin<br>Zirconium dioxide<br>Iron oxide<br>silica<br>Calcium tungstate<br><br>Catalyst<br>amine-containing paste | Paste A<br>Bisphenol A epoxy resin<br>Bisphenol F epoxy resin<br>zirconium oxide<br>Iron oxide Pigments<br>silica<br>Calcium tungstate<br><br>Paste B<br>amine-containing paste | The main<br>ingredients<br>of AH Plus<br>and of Dia-<br>Proseal<br>are similar.<br>They are<br>both two-<br>component<br>system<br>that use<br>epoxide/<br>amine<br>reaction to<br>cause<br>setting. | | Resin Sealer<br>Type | Epoxy resin based sealers | Epoxy resin based sealers | equivalent | | Device<br>description | DiaProSeal Root Canal Sealer consists<br>of two components, the epoxy resin<br>paste(Base) and the amine-containing<br>paste(Catalyst) portions which are<br>mixed prior to insertion into the root<br>canal.<br><br>DiaProSeal Root Canal Sealer is two-<br>component systems that react via an<br>epoxide/amine chemical reaction to<br>cause setting. | AH Plus Root Canal sealer is a two-<br>component paste: paste root canal<br>sealer based on epoxy-amine rein<br>chemistry. This is easy-to-mix sealer<br>adapts closely to the walls of the<br>prepared root canal and provides<br>outstanding long-term dimensional<br>stability with minimal shrinkage upon<br>setting.<br><br>The final product consists of two<br>components, the epoxy resin<br>paste(PasteA) and the amine-<br>containing paste(PasteB) portions<br>which are mixed prior to insertion into<br>the root canal | equivalent | | Direction<br>for | Application Method | Preparation | equivalent | | | | | | | Use | 1. Isolate the site with rubber dam.<br>Prepare and shape the root canal. | 1. Prior to the application of the | | | | 2. Remove any debris inside the root<br>canal. Disinfect and clean the root canal<br>thoroughly with Sodium Hypochlorite or<br>EDTA solution and dry it completely. | material prepare, clean, and dry the<br>root canals to be filled using state-of-<br>the-art endodontic techniques. | | | | 3) Open the safety cap of DIAPROSEAL<br>and squeeze out the vase material<br>(yellow) and the catalyst material(white)<br>in 1:1 ratio from the dual syringe onto a<br>mixing pad. (Due to the different<br>viscosity of the vase material and the<br>catalyst material, they may be dispensed<br>at a different speed). | Dosage and mixing | | | | 4. Using a mixing stick or metal spatula,<br>mix the base material (yellow) and the<br>catalyst material(white) for 10-20<br>seconds until they are completely mixed<br>together and have turned into an ivory<br>color. | 1. Using a metal spatula 2, mix equal<br>volume units (1:1) of paste A (amber<br>color) and paste B (white color) of AH<br>Plus® root canal sealer on a glass slab<br>or the mixing pad supplied with the<br>package. Mix to a homogeneous<br>consistency. | | | | 5. Measure the length of the root canal<br>by using an electronic apex locator or a<br>file. Select a gutta percha point<br>accordingly. Apply and coat a small<br>amount of the mixture to the gutta<br>percha point and insert the point towards<br>the apex slowly. alternatively, dentists<br>may choose to apply the mixture with a<br>paper point, a reamer, or Dia-Spiral Filler<br>(Lentulo spiral). In order to Prevent the<br>formation and entrapment of air bubbles<br>and overfilling the canal, the mixture-<br>coated points must be inserted very<br>slowly in a clockwise direction during<br>obturation and withdrawn in a counter<br>clock wise direction. If Lentulo spiral is<br>used, advance and withdraw the Lentulo<br>spiral slowly to the apex at very low<br>speed. | 2. Tightly close tubes after use.<br>3. Do not exchange caps of tubes. The<br>white cap belongs to paste A; the grey<br>сар<br>belongs to paste B.<br><br>Master-Point-Technique<br>1. Select a gutta-percha point (or<br>alternatively a paper point or a reamer)<br>of the size of the last instrument used<br>during apical preparation.<br>2. Wet the canal walls with the material<br>through a pumping or simultaneously<br>rotating movement in a counter-<br>clockwise direction of the<br>point/reamer. Alternatively, apply the<br>material onto the tip of a Lentulo spiral.<br>3. Advance the Lentulo spiral slowly to<br>the apex running at very low speed.<br>Avoid the<br>formation of air bubbles in the material<br>and overfilling of the canal.<br>4. Withdraw Lentulo very slowly still<br>running at low speed.<br>5. Dip disinfected and dry master point<br>into the material and insert it into the<br>canal with<br>a slow pumping motion. | | | | 6. Once the procedure is done, take an<br>X-Ray to check the seal. | | | {5}------------------------------------------------ {6}------------------------------------------------ | Chemical<br>reaction<br>mechanism | | | equivalent | |------------------------------------------|------------------------------------------------------------------------------------|-------------------------------------------------------------------------|------------| | Performance<br>Standard<br>Conformance | ISO6876 | ISO6876 | equivalent | | Physical and<br>Mechanical<br>Properties | -. setting time<br>-. Film thickness<br>-. radiopacity<br>-. solubility<br>-. Flow | -. Working time<br>-. film thickness<br>-. radiopacity<br>-. Solubility | equivalent | | Biocompatibility | Yes | Yes | equivalent | | Use | Prescription/Hospital | Prescription/Hospital | equivalent | | Delivery forms<br>(Design) | Manual mixing of Base and Catalyst | Manual mixing of paste A and Paste B | equivalent | As demonstrated in the above comparison table, the subject and predicate devices have similar indication for uses, main ingredients, contents, biocompatibility, and conformance with standards. Also, the subject and predicate devices are using the same chemical reaction and classified as the same resin type (Epoxy resin based sealers) as a two part mixture design. {7}------------------------------------------------ # 5.6 Non-Clinical Performance Data This device has demonstrated conformance with non-clinical performance requirements through evaluation and testing in accordance with the following standards: | Standards | Contents | Relevant Tests<br>(Performed) | |-------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------| | ISO 7405:2008 | Dentistry—Evaluation of biocompatibility of<br>medical devices used in dentistry | - | | ISO 10993-1:2009 | Biological evaluation of medical devices - Part<br>1: Evaluation and testing within a risk<br>management process | - | | ISO 10993-3:2014 | Biological evaluation of medical devices - Part<br>3: Tests for genotoxicity, carcinogenicity and<br>reproductive toxicity | •Bacterial Reverse<br>mutation | | ISO 10993-5:2009 | Biological evaluation of medical devices - Part<br>5: Tests for in vitro cytotoxicity | •Cytotoxicity | | ISO 10993-10:2010 | Biological evaluation of medical devices - Part<br>10: Tests for irritation and skin sensitization | •Sensitization<br>•Irritation/Intracutaneous<br>reactivity | | ISO 10993-11:2017 | Biological evaluation of medical devices - Part<br>11: Tests for systemic toxicity | •Acute systemic toxicity | | ISO 6876:2012 | Dentistry — Root canal sealing materials | •Setting time<br>•Film Thickness<br>•Radio-opacity<br>•Solubility<br>•Flow | ## 5.7 Clinical Performance Data No clinical data was collected or provided to support substantial equivalence between the subject and predicate devices. ## 5.8 Conclusions Based on conclusions drawn from the testing results, the substantially equivalent to our legally marketed predicate device.