NeoPEX™ Pre-Mixed Obturation Paste

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION September 4, 2026 NuSmile, Ltd. Priscilla Lara QA/RA Manager 3315 W. 12th St. Houston, Texas 77008 Re: K253909 Trade/Device Name: NeoPEX™ Pre-Mixed Obturation Paste Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF, EJK Dated: August 5, 2026 Received: August 5, 2026 Dear Priscilla Lara: 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 (the 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 available 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K253909 - Priscilla Lara Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K253909 - Priscilla Lara Page 3 assistance/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 -S Michael E. Adjodha, MChE, RAC, CQIA 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 {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K253909 | ? | | Please provide the device trade name(s). | | ? | | NeoPEX™ Pre-Mixed Obturation Paste | | | | Please provide your Indications for Use below. | | ? | | • Obturation and sealing of root canals following extirpation and pulpectomy • Vital Pulpotomy • Pulp capping • Repair of Root Resorption • Apexification and/or Perforations • Root canal filling for primary teeth | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} # 510(k) SUMMARY-K253909 Submitter NuSmile, Ltd. Proprietary Name NeoPEX™ Pre-Mixed Obturation Paste Common Name Root Canal Filling Material Classification Root Canal Filling Material 21 CFR 872.3820 Product Code: KIF, EJK Predicate Devices Primary Predicate - nRoot SP (K250710) Reference Predicate Devices - nRoot BP (K251465) - MTA2.3 Root & Pulp Materials (K181917) - UltraCal XS (K211905) Device Description NeoPEX™ Pre-Mixed Obturation Paste is a non-sterile, premixed hydraulic calcium silicate material containing calcium hydroxide and is supplied in a prefilled syringe with disposable dispensing tips for direct clinical placement. The material hardens in the presence of moisture to form a calcium silicate cement, creates a highly alkaline local environment, and releases calcium. NeoPEX is radiopaque to facilitate radiographic visualization following placement. Indications for Use - Obturation and sealing of root canals following extirpation and pulpectomy - Vital Pulpotomy - Pulp capping - Repair of Root Resorption - Apexification and/or Perforations - Root canal filling for primary teeth {5} # Summary of substantial Equivalence | | Subject Device NeoPEX (K253909) | Primary Predicate nRoot SP (K250710) | Additional Predicate nRoot BP (K251465) | Reference Device MTA 2.3 (K181817) | Reference Device UltraCal XS (K211905) | Comments | | --- | --- | --- | --- | --- | --- | --- | | Indications for Use | • Obturation and sealing of root canals following extirpation and pulpectomy • Vital Pulpotomy • Pulp capping • Repair of Root Resorption • Apexification and/or Perforations • Root canal filling for primary teeth | • Permanent obturation of the root canal following vital pulp extirpation • Permanent obturation of the root following removal of infected or necrotic pulp and placement of intracanal dressings • Suitable for use in single cone and lateral condensation technique | Root canal repair material (nRoot BP) is developed for permanent root canal sealer and repair and surgical applications • Repair of root perforation • Root end filling apexification • Pulp capping | • Apexification and/or perforation • Vital pulpotomy • Direct pulp capping • Obturation and sealing of root canals | UltraCal XS calcium hydroxide paste is indicated to be used for: • Temporary dressing for root canals • Apexification and/or perforation • Vital pulpotomy • Direct pulp capping • Indirect pulp capping • Root resorption • Root canal filling for primary teeth | Similar The Indications for Use of the Subject Device are within that of the predicate and reference devices | | Form | • Premixed flowable paste | • Premixed flowable paste | Premixed flowable paste | • Premixed flowable paste | Premixed flowable paste | Equivalent | | Delivery System | • Pre-loaded paste in Syringe with Dispensing Tips | • Pre-loaded paste in Syringe with Dispensing Tips | Pre-loaded paste in Syringe with Dispensing Tips | • Pre-loaded paste in Syringe with Dispensing Tips | Pre-loaded paste in Syringe with Dispensing Tips | Equivalent | | Composition | • Tricalcium Silicate • Dicalcium Silicate • Calcium Hydroxide • Tantalum Pentoxide • Organic Fluids and Thickener | • Tricalcium Silicate • Dicalcium Silicate • Calcium Hydroxide • Zirconium Dioxide • Thickener | • Tricalcium Silicate • Dicalcium Silicate • Calcium Hydroxide • Calcium Phosphate • Zirconium Dioxide • Thickener | • Tricalcium Silicate • Dicalcium Silicate • Tantalum Pentoxide • Organic Fluids and Thickener | • Calcium Hydroxide • Water • Barium Sulfate • Propylene Glycol • Hydroxypropyl Methylcellulose | Similar Calcium Silicate cements (except UltraCal XS – not a cement); All release Calcium Hydroxide | | Setting | • Sets per ISO 6876 | • Sets per ISO 6876 | • Sets per ISO 6876 | • Sets per ISO 6876 | Non-setting | Similar Cements that set as per ISO 6876 (except UltraCal XS – not a cement) | {6} | | Subject Device NeoPEX (K253909) | Primary Predicate nRoot SP (K250710) | Additional Predicate nRoot BP (K251465) | Reference Device MTA 2.3 (K181817) | Reference Device UltraCal XS (K211905) | Comments | | --- | --- | --- | --- | --- | --- | --- | | Physical Properties | - Conforms to applicable parts of ISO 6876 | - Conforms to applicable parts of ISO 6876 | - Conforms to applicable parts of ISO 6876 | - Conforms to applicable parts of ISO 6876 | Conforms to applicable parts of ISO 6876 | Equivalent | | Calcium Ion Releasing | - Yes | - Yes | - Yes | - Yes | Yes | Equivalent | | pH when hydrated | - >11 | - >11 | - >11 | - >11 | >11 | Equivalent High pH environment due to Calcium Hydroxide release | | Radiopacity | - >3mm | - >3mm | - >3mm | - >3mm | >3mm | Equivalent | | Sterility | - Non-sterile | - Non-sterile | - Non-sterile | - Non-sterile | Non-sterile | Equivalent | | Shelf Life | - 2 years | - 2 years | - 2 years* | - 2 years* | 2 years* | Equivalent (*based on product literature) | {7} ## Summary of Non-Clinical Testing Performance testing was conducted in accordance with ISO 6876, to evaluate the technological characteristics of the subject device and support substantial equivalence to the identified predicate and reference devices. Results for Flow, Setting, radiopacity, pH on setting, and calcium ion release for the subject device were equivalent or very similar to predicate devices. Biocompatibility was demonstrated in accordance with the FDA guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". No clinical studies were required to support substantial equivalence. ## Conclusion The results of the nonclinical testing demonstrate that NeoPEX™ Pre-Mixed Obturation Paste performs as intended and has the same intended use and similar technological characteristics as the identified predicate and reference devices. Based on the information provided, NeoPEX™ Pre-Mixed Obturation Paste is substantially equivalent to the identified predicate devices. Any differences between the subject device and the predicate and reference devices do not raise different questions regarding safety or effectiveness.