NaturaJel™ Oral Wound Care Kit

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION August 5, 2026 HCS Innovation, LLC Peter Catalano Official Correspondent 384 Highlands Court Union Grove, Alabama 35175 Re: K260120 Trade/Device Name: NaturaJel™ Oral Wound Care Kit Regulatory Class: Unclassified Product Code: OLR Dated: July 21, 2026 Received: July 21, 2026 Dear Peter Catalano: 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} K260120 - Peter Catalano 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} K260120 - Peter Catalano 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. | K260120 | ? | | Please provide the device trade name(s). | | ? | | NaturaJel™ Oral Wound Dressing | | | | Please provide your Indications for Use below. | | ? | | NaturaJel adheres to oral mucosal tissue and forms a protective barrier over wounds or ulcers to prevent further irritation and contamination. It provides a moist wound environment required for optimal healing. | | | | NaturaJel manages pain associated with: • Oral mucosal wounds, sores, injuries, and ulcers • Canker sores and cold sores • Irritation from orthodontic appliances (braces, brackets, expanders), dentures, and partials • Soft tissue pain from orthodontics, aphthous ulcers, and extraction sites | | | | 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- K260120 Submitted By: HCS Innovation, LLC 384 Highlands Union Grove, AL 35175 Ph:256-293-3755 Contact Person: Peter Catalano, MD 617-999-2973 Date Prepared: August 4, 2026 Proprietary Name: NaturaJel™ Oral Wound Dressing 510(k) Number: K260120 Common Name: Hydrogel Oral Wound Dressing Device Class: Unclassified Panel: Dental Product Code: OLR, MGQ Predicate: OraSoothe® SockIt! (K063148) # Device Description: NaturaJel™ is a topical gel with mushroom chitosan and sodium alginate biopolymers in sterile water. NaturaJel™ is provided in a prefilled single use syringe ready for use allowing for application directly to the tissue site or application via a dental/medical instrument of their choice (e.g. a cotton tipped swab, Hurd Elevator or similar applicator). # Indications For Use: NaturaJel adheres to oral mucosal tissue and forms a protective barrier over wounds or ulcers to prevent further irritation and contamination. It provides a moist wound environment required for optimal healing. NaturaJel manages pain associated with: - Oral mucosal wounds, sores, injuries, and ulcers - Canker sores and cold sores - Irritation from orthodontic appliances (braces, brackets, expanders), dentures, and partials - Soft tissue pain from orthodontics, aphthous ulcers, and extraction sites {5} # Substantial Equivalence: NaturaJel™ Oral Wound Dressing is similar technologically to the predicate device, OraSoothe® SockIt!: both are polysaccharide-based dressings that when applied to oral tissue provide a protective layer over compromised tissue. Both NaturaJel Oral Wound Dressing and OraSoothe SockIt! manages pain associated with the indicated wounds or ulcers by coating damaged oral tissue and protecting the tissue from further contamination and irritation. Bench testing performed to examine tissue adherence demonstrated substantial equivalence to the predicate device. Table 1: Comparison of Subject Device and Predicate | Comparison Parameters | Subject Device-NaturaJel™ Oral Wound Dressing (K260120) | Predicate - OraSoothe® SockIt! (K063148) | | --- | --- | --- | | Indications for Use | NaturaJel adheres to oral mucosal tissue and forms a protective barrier over wounds or ulcers to prevent further irritation and contamination. It provides a moist wound environment required for optimal healing. NaturaJel manages pain associated with: • Oral mucosal wounds, sores, injuries, and ulcers • Canker sores and cold sores • Irritation from orthodontic appliances (braces, brackets, expanders), dentures, and partials • Soft tissue pain from orthodontics, aphthous ulcers, and extraction sites | This product manages the pain in all types of oral wounds, mouth sores, injuries and ulcers of the oral mucosa. It adheres to oral tissue and forms a protective barrier between the wound and further irritation and contamination. It provides the moist wound environment required for optimal wound healing. Manages pain of, for example: • All types of oral wounds, mouth sores, injuries and ulcers of the oral mucosa • Canker sores and cold sores • Irritation and traumatic ulcers such as those caused by various appliances such as braces, brackets, full and partial dentures and | {6} | | | palatal expanders • Soft tissue pain from orthodontics Aphthous ulcers • Extraction site pain • Oral mucositis and stomatitis Irritation and pain following tooth scaling and prophylaxis. | | --- | --- | --- | | Area of Use | Oral Tissue | Oral Tissue | | Chemical Characteristics | Polysaccharides. The blue dye allows for visual confirmation of complete coverage. | Polysaccharides | | Applications | Once per wound | Multiple per wound | | Use | Single Use | Multiple use per patient | | Prescription/OTC | Prescription | Prescription and OTC | | Intended User | Medical/Dental Professional | Medical/Dental Professional and consumers | | Type of Product | Ready for Use | Ready for Use | # Non-clinical Performance Testing: Bench testing comparing NaturaJel™ and OraSoothe® SockIT! were performed. The results were substantially equivalent for NaturaJel and the predicate, providing further evidence of substantial equivalence. The testing consisted of physical properties testing including the following: - Viscosity - pH - Shear Testing for Adhesion - Evaluation of Calcium Acetate Treatment {7} ### Biocompatibility: *In vitro* and *In vivo* biocompatibility testing according to ISO 10993 standards for Cytotoxicity, Sensitization, Acute Systemic Toxicity and Irritation were performed. ### Clinical Performance Testing: No clinical performance testing was conducted. ### Conclusions: Based upon technologic characteristics as well as the results of comparative non-clinical performance testing, and biocompatibility testing, we believe that NaturaJel™ is substantially equivalent to the predicate K063148.