Biodentine XP 500, Biodentine XP 200

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. August 10, 2021 Septodont Greg Montgomery Business Operations Manager 205 Granite Run Drive, Suite 150 Lancaster, Pennsylvania 17601 Re: K211799 Trade/Device Name: Biodentine XP 500, Biodentine XP 200 Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: June 4, 2021 Received: June 10, 2021 #### Dear Greg Montgomery: 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 {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/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, Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K211799 Device Name Biodentine XP 500, Biodentine XP 200 #### Indications for Use (Describe) In the crown: For temporary teeth (children from 2 years of age) and permanent teeth (immature or mature): - Permanent dentine restoration under composites or Inlay/Onlay - Temporary dentine-enamel restoration; - Restoration of deep and/or large coronal carious lesions (sandwich technique); - Restoration of cervical or radicular lesions. On the pulp: For temporary teeth (children from 2 years of age) and permanent teeth (immature or mature): - Pulp capping (direct and indirect). - Pulpotomy for diagnosed symptoms of reversible pulpitis where bleeding is controlled within 5 minutes. In the root: For permanent teeth (immature or mature): - Repair of root perforations; - Repair of furcation perforations; - Repair of perforating internal resorptions; - Repair of external resorption; - Root-end filling in endodontic surgery (retrograde filling). For immature permanent teeth - Apexification; Type of Use (Select one or both, as applicable) X 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}------------------------------------------------ #### 5. 510(K) SUMMARY #### K211799 # Septodont Biodentine™ XP 500, Biodentine™ XP 200 (per 21CFR 807.92) #### 1. SUBMITTER/510(K) HOLDER Septodont 58, rue du Pont de Créteil 94107 Saint-Maur-des-Fossés, Cedex France Phone: 331-49-76-71-16 Establishment Registration No: 9610964 Contact: Leslie Fillion, Regulatory Affairs Manager Contact Phone: +1-(519)-623-4800, x6354 Contact Email: lfillion(@septodont.com Date Prepared: 08/09/2021 #### 2. DEVICE NAME | Device Name: | Biodentine™ XP 500, Biodentine™ XP 200 | |------------------------------|------------------------------------------------------------| | Device Classification Name: | Resin, Root Canal Filling/Liner, Cavity, Calcium Hydroxide | | Regulation Number: | primary : 872.3820 | | Classification Product Code: | primary: KIF | | Device Class: | II | #### 3. PREDICATE DEVICE | Manufacturer: | Septodont | |------------------------------|------------------------------------------------------------| | Device Name: | BiodentineTM | | Device Classification Name: | Resin, Root Canal Filling/Liner, Cavity, Calcium Hydroxide | | 510(k) Number: | K140132 | | Regulation Number: | primary: 872.3820, secondary: 872.3275 | | Classification Product Code: | primary: KIF, secondary: EMA | | Device Class: | II | #### 4. DEVICE DESCRIPTION Biodentine™ XP 500, Biodentine™ XP 200 is a bioactive dentin substitute. The product is prepared from a mixture of a Biodentine™ XP 500, Biodentine™ XP 200 powder and a liquid. The product is presented in all-in-one cartridge containing thepowder phase and the liquid phase, ready to be mixed. {4}------------------------------------------------ The medical device is presented in two presentations, the Biodentine™ XP 500 for the extraction of 500mg of finished product and the Biodentine™ XP 200 for the extraction of 200mg of finished product. The subject device is to be used with 2 accessories, the Biodentine™ Mixer and the Biodentine™ Gun. #### 5. INTENDED USE Bioactive dentin substitute. #### 6. INDICATIONS FOR USE In the crown: For temporary teeth (children from 2 years of age) and permanent teeth (immature or mature): - Permanent dentine restoration under composites or Inlav/Onlav - Temporary dentine-enamel restoration; - Restoration of deep and/or large coronal carious lesions (sandwich technique); - Restoration of cervical or radicular lesions. ## On the pulp: For temporary teeth (children from 2 years of age) and permanent teeth (immature or mature): - Pulp capping (direct and indirect). - Pulpotomy for diagnosed symptoms of reversible pulpitis and irreversible pulpitis where bleeding is controlled within 5 minutes. In the root: For permanent teeth (immature or mature): - Repair of root perforations; - Repair of furcation perforations; - Repair of perforating internal resorptions; - Repair of external resorption: - Root-end filling in endodontic surgery (retrograde filling). For immature permanent teeth - Apexification: ## 7. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE/S Septodont demonstrated that, Biodentine™ XP 500, Biodentine™ XP 200 is substantially equivalent in indications and design principles to its predicate device, Septodont's Biodentine™ device, K140132 (cleared on June 27th 2014). The subject device and the predicate device have intended used, similar indication for use, same technological characteristics and are made of same materials. Any differences in their methods of application do not raise any new issues of safety or efficacy for the Biodentine™ XP 500, Biodentine™ XP 200 device. #### 8. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE {5}------------------------------------------------ Biodentine™ XP 500, Biodentine™ XP 200 have undergone extensive bench testing to provide evidence that its physical-chemical properties are substantially equivalent to the Biodentine™ predicate device. Both devices are providednon-sterile, have comparable aspect, working time, setting time, compressive strength, sealing ability, pH, porosity, u hardness and radiopacity. Biological equivalence has been demonstrated between the subject device, Biodentine™ XP 500, Biodentine™ XP 200 and predicate device, Biodentine™ allowing Septodont to conclude based on Biodentine™ biocompatibilitydata, that Biodentine™ XP 500, Biodentine™ XP 200 is not mutagenic nor a sensitizer or irritant and does not induce any systemic toxicity. It is considered as fully biocompatible and equally bioactive as it is able to induce the mineralization processes. ## 9. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE No clinical data was collected using Biodentine™ XP 500. Biodentine™ XP 200 to support substantial equivalence between the subject and the predicate devices. Clinical equivalence between the two devices has been demonstrated based on the equivalence demonstration in terms of intended use/indications for use, physico- mechanical, chemical, bioactivity and biological properties. Furthermore, devices are used for the same clinical condition, including similar severity and stage of disease, at the same site in the body (crown, pulp or root of the tooth), in contact with the same tissues (enamel, dentine, pulp), in same population (adult and pediations from 2 years age) and has same relevant critical performance in view of the expected clinical effect for a specific intended purpose. Consequently, the use of the clinical evaluation data obtained using the Biodentine™ is sufficient to demonstrate clinical conformity for the Biodentine™ XP 500, Biodentine™ XP 200. # 10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS The subject device, Biodentine™ XP 500, Biodentine™ XP 200 and its predicate device Biodentine™ are designated for equivalentbioactive dentin substitute and have comparable chemical, physical and performance specifications. Both products have equivalent shelf-life. Based on the above information and data provided in this submission, the subject device has been demonstrated to be substantially equivalent to Septodont's cleared device, Biodentine™ (K140132, cleared on 06-27-2014). | | | | Table 5-1. Side-by-Side Comparison of Biodentine™ XP 500, Biodentine™ XP 200 with | | | | |--|-------------------------------|--|-----------------------------------------------------------------------------------|--|--|--| | | Predicate Device Biodentine™. | | | | | | | Characteristic | Subject:<br>Biodentine™ XP<br>500,<br>Biodentine™ XP<br>200 | Predicate:<br>Biodentine™(K140132;<br>cleared on 2014 June 27th) | Comparison<br>(Same,<br>Similar,<br>Different) | | |-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Septodont | Septodont | Same | | | Classification device code | KIF | KIF / EMA | Same | | | Classification Name | Resin, Root canal filling | Resin, Root canal filling | Same | | | Class | Class II | Class II | Same | | | Intended Use | Bioactive dentine substitute | Bioactive dentine substitute | Same | | | Indications | In the crown:<br>For temporary teeth (children<br>from 2 years of age) and | In the crown: | Similar | | | Characteristic | Subject:<br>Biodentine™ XP<br>500,<br>Biodentine™ XP<br>200 | Predicate:<br>Biodentine™(K140132;<br>cleared on 2014 June 27th) | Comparison<br>(Same,<br>Similar,<br>Different) | | | | permanent teeth (immature<br>or mature)<br>- Permanent dentine<br>restoration under<br>composites or Inlay/Onlay<br>- Temporary dentine-<br>enamel restoration<br>- Restoration of deep<br>and/or large coronal<br>carious lesions (sandwich<br>technique).<br>- Restoration of cervical<br>or radicular lesions | -Permanent dentine<br>restoration under composites<br>or Inlay/Onlay<br>-Temporary dentine-enamel<br>restoration.<br>-Restoration of deep and/or<br>large coronal carious lesions<br>(sandwich technique).<br>-Restoration of cervical<br>radicular lesions. | | | | | On the pulp:<br>For temporary teeth (children<br>from 2 years of age) and<br>permanent teeth (immature<br>or mature)<br>- Pulp capping (direct and<br>indirect)<br>- Pulpotomy for diagnosed<br>symptoms of reversible<br>pulpitis and irreversible<br>pulpitis where bleeding is<br>controlled within 5<br>minutes | -Pulp capping.<br>-Pulpotomy. | Similar | | | | In the root:<br>For permanent teeth<br>(immature or mature)<br>- Repair of root perforations.<br>- Repair of furcation<br>perforations<br>- Repair of perforating<br>internal resorptions<br>- Repair of external<br>resorption<br>- Root-end filling in<br>endodontic surgery<br>(retrograde filling) | In the root:<br>- Repair of root perforations.<br>- Repair of furcation<br>perforations.<br>- Repair of perforating<br>internal resorptions.<br>- Repair of external<br>resorption<br>- Root-end filling in<br>endodontic surgery<br>(retrograde filling). | Similar | | | Characteristic | Subject:<br>Biodentine™ XP<br>500,<br>Biodentine™ XP<br>200 | Predicate:<br>Biodentine™(K140132;<br>cleared on 2014 June 27th) | Comparison<br>(Same,<br>Similar,<br>Different) | | | | For immature permanent<br>teeth:<br>- Apexification | - Apexification. | | | | User population | Biodentine™ XP 500,<br>Biodentine™ XP 200 is<br>intendedto be applied on<br>temporary teeth (from 2<br>years old), on permanent<br>teeth (mature or immature)<br>or on non-vital immature<br>permanent teeth<br>depending on indication. | Information not provided in<br>Biodentine™ label submitted<br>in K140132. | Similar;<br>User population<br>information in<br>label is now<br>required for all<br>Septodont's<br>product | | | Prescription/ over-the- | Prescription | Prescription | Same | | | counter use<br>Single-use /multiple use | Single use | Single use | Same | | | Galenic Forms | Powder/Liquid | Powder/Liquid | Same | | | Ingredients | Powder: tricalcium silicate,<br>zirconium oxide, calcium<br>oxide, calcium carbonate,<br>iron-oxide based pigments<br>Liquid: calcium chloride,<br>polycarboxylate, purified<br>water | Powder: tricalcium silicate,<br>zirconium oxide, calcium<br>oxide, calcium carbonate,<br>iron-oxide based pigments<br>Liquid: calcium chloride,<br>polycarboxylate, purified<br>water | Same | | | Ingredients quantity | | | | | | | XP500:<br>Powder: 700mg<br>Liquid: 190µL<br><br>XP200 :<br>Powder: 450mg<br>Liquid: 122µL | Capsule of powder : 700mg<br>Single-dose container of<br>liquid : 250µL<br>The dental healthcare<br>professional put 5 or 6 drops<br>into the capsule powder i.e<br>173µL to 208µL | Similar; ratio<br>powder/liquid<br>(w/w) is<br>equivalent for<br>subject device<br>(XP500 (3.04)<br>and XP200<br>(2.91))<br>compared to<br>predicate<br>device<br>(between 2.79<br>and 3.34). | | | Liquid formulation | In XP200 and XP500<br>formulation:<br>For 100 g quantity:<br>Plasticizer: 0.5 g<br>Purified water: 70.10 g | For 100 g quantity:<br>Plasticizer: 2.0 g<br>Purified water: 68.60 g | Similar;<br>BiodentineTM<br>XP liquid<br>formulation is<br>similar to<br>BiodentineTMliq<br>uid formulation. | | | Characteristic | Subject:<br>BiodentineTM XP<br>500,<br>BiodentineTM XP<br>200 | Predicate:<br>BiodentineTM(K140132;<br>cleared on 2014 June 27th) | Comparison<br>(Same,<br>Similar,<br>Different) | | | | | | | The ingredients<br>are the same<br>but the quantity<br>for the<br>plasticizer<br>agent and the<br>purified water<br>are different<br>from the<br>predicate.<br>Performance<br>equivalence has<br>been<br>demonstrated<br>on subject and<br>predicate<br>finished<br>products<br>demonstrating<br>that the<br>difference in<br>plasticizer<br>quantity in the<br>liquid<br>formulation<br>does not impact<br>product<br>specifications<br>when compared<br>subject device<br>(XP500 and<br>XP200) to<br>predicate<br>device. | | Containers | Powder and liquid are<br>packaged in the all-in-one<br>Biodentine™ XP 500,<br>Biodentine™ XP 200<br>single-dose cartridge | Powder in capsule<br>Liquid in single-dose<br>container | Different;<br>however,<br>stability results<br>obtained for<br>subject device<br>provide<br>equivalent shelf<br>life than the | | | Characteristic | Subject:<br>Biodentine™ XP<br>500,<br>Biodentine™ XP<br>200 | Predicate:<br>Biodentine™(K140132;<br>cleared on 2014 June 27th) | Comparison<br>(Same,<br>Similar,<br>Different) | | | | | | | | | | | | predicate<br>device.<br>Human factor<br>study has<br>provided<br>evidence of<br>safety and<br>effectiveness<br>for the subject<br>device. | | | Mixing and Dispensing | Mixing: using the<br>BiodentineTM Mixer<br>Dispensing: using the<br>BiodentineTM Gun dispenser<br>by the dental healthcare<br>specialist | Mixing: using a mixer<br>Dispensing: Manually by the<br>dental healthcare specialist | Same for<br>mixing step.<br><br>Different for<br>the dispensing<br>step, however<br>human factor<br>study has<br>provided<br>evidence of<br>safety and<br>effectiveness<br>for the subject<br>device. | | | Working Time | ≥ 1min | ≥ 1min | Same | | | Setting Time (at 37°C) | 9 to 25 min<br>(average time of 12.5<br>minutes) | 9 to 25 min<br>(average time of 12.5<br>minutes) | Same | | | Compressive strength | ≥ 150 MPA at 24h | ≥ 150 MPA at 24h | Same | | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------