Profisil Free

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION September 3, 2026 Kettenbach GmbH & Co. KG Marleen Steger Regulatory Affairs Manager Im Heerfeld 7 Eschenburg, 35713 GERMANY Re: K262243 Trade/Device Name: Profisil® Free Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: Class II Product Code: LBH Dated: July 1, 2026 Received: July 1, 2026 Dear Marleen Steger: 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} K262243 - Marleen Steger 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} K262243 - Marleen Steger 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} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # **Indications for Use** Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K262243 Device Name Profisil Free (14823); Profisil Free (14825); Profisil Free (14833); Indications for Use (Describe) Profisil® Free produces mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity. 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.** 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."* FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} K262243 KETTENBACHDENTAL Simply intelligent ## 510(k) Summary I. Submitter: Kettenbach GmbH & Co KG Im Heerfeld 7 35713 Eschenburg Germany Phone: +49 2774 705 0 Contact person: Steger, Marleen Regulatory Affairs Manager Im Heerfeld 7 35713 Eschenburg Germany Phone: + 49 277 4705 0 E-mail: marleen.steger@kettenbach.com Date of preparation: September 3rd, 2026 II. Device Name of Device: Profisil® Free Common or Usual Name: Profisil® Free Classification Name: Dental, Varnish, Cavity (21 CFR 872.3260) Regulatory Class: II Product Code: LBH 510k Summary Issued: 2026-09-03 Rev. 3 Page 1 von 6 {5} KETTENBACHGENTAL Simply intelligent ### **III. Predicate device:** ReminGel® (Inter-Med, Inc. / Vista Apex), K241489 This predicate has not been subject to a design-related recall. No reference devices were used in this submission. ### **IV. Device Description:** Profisil® Free is designed to securely adhere to the tooth surface for several hours while releasing calcium and phosphate ions. The varnish features a mucosa-friendly dimethicone gel. ### **V. Indications for Use:** Profisil® Free produces mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity. 510k Summary Issued: 2026-09-03 Rev. 3 Page 2 von 6 {6} KETTERBACHMENTAL Simply intelligent VI. Table 1: COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | | Predicate Devices | Substantial Equivalent Device | Conclusion | | --- | --- | --- | --- | | Product | ReminGel® | Profisil® Free | | | Manufacturer | Inter-Med, Inc. / Vista Apex | Kettenbach GmbH & Co. KG | | | Device Description | ReminGel is a convenient, premixed, ready-to-use, opaque aqueous-based gel. ReminGel consists of suspended hydroxyapatite and calcium and phosphate salts that help to restore a tooth's hydroxyapatite structure through remineralization. This remineralization results in tubule occlusion and blocks fluid flow in dentinal tubules, thereby relieving dentinal sensitivity. Additionally, Remin Gel blocks nerve excitability through potassium release. | Profisil Free is designed to securely adhere to the tooth surface for several hours while releasing calcium and phosphate ions. The varnish features a mucosa-friendly dimethicone gel. | Treatment of hypersensitivity teeth is the technological which is based on releasing calcium and phosphate ions for both devices. | | Intended purpose | Dental Desensitizing / Remineralizing Agent | Fluoride free varnish for the treatment of dentinal hypersensitivity | The intended purpose is the same in substance. | | Indication | To relieve dental hypersensitivity caused by bleaching procedures, cold heat, acids, or sweets. | Profisil Free produces mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity. | The indication is the same in substance. | | Basic formulation | Potassium Salt, **Calcium Salt**, **Phosphate Salts**, Buffering Agents, pH Modifier, Sweetener, Thickener, Flavoring, Water | Polydimethylsiloxane, Hydroxyapatite, **Calcium Salts**, **Phosphate Salts**, Sweetener*, Film forming organic polymer, Flavor* *Not included in "unflavored" version | Calcium salts and phosphate salts are included in both products. The base of the formulation is different. | | Packaging | ReminGel is packed in a 3 oz (90 mL) tube. The tube of ReminGel is placed into a printed cardboard bearing instructions for use and appropriate labeling. | Profisil Free is packed in a single-dose blister containing 0.5 ml varnish material and an applicator brush placed in a modeled tray closed with a seal. | The delivery system for both products is different. The difference does not affect the intended use, mechanism of action, formulation, performance characteristics, or application of the device. The single-dose blister delivers the same product to the patient and does not raise different questions of safety and effectiveness. | 510k Summary Issued: 2026-09-03 Rev. 3 Page 3 von 6 {7} KETTERBACHMENTAL Simply intelligent | | Predicate Devices | Substantial Equivalent Device | Conclusion | | --- | --- | --- | --- | | Product | ReminGel® | Profisil® Free | | | Manufacturer | Inter-Med, Inc. / Vista Apex | Kettenbach GmbH & Co. KG | | | | | | Stability testing demonstrates that the product remains safe and effective throughout its labeled shelf life. Therefore, the packaging difference does not impact the determination of substantial equivalence. | | Intended population | Patients with dentinal hypersensitivity | Patients with dentinal hypersensitivity | The patient population is identical. | | Delivery Form / Method of application | ReminGel can be applied to teeth using dental appliances (e.g. fluoride tray, whitening tray, periotray, etc.) or via a toothbrush. | Product placed direct onto teeth / affected area using applicator brush. | Both products are applied to the teeth. | | Mechanism of Action / Principle of Operation | Dentin tubule occlusion | Dentin tubule occlusion | The Mechanism of Action is identical. | | | The material physically blocks or occludes patent / open dentin tubules on the dentition. | The material physically blocks or occludes patent / open dentin tubules on the dentition. | The Principle of Operation is identical. | | Anatomical site | Oral cavity | Oral cavity | Both devices are used in the oral cavity. | | Contraindications / Precautions | Do not use ReminGel in patients with a known allergy to any of the product's ingredients. An allergic reaction may require treatment. | Ulcerative gingivitis and stomatitis. If any signs of inflammation or allergic reaction occur, discontinue use immediately and refrain from further use with this patient. Allergic reactions to the products cannot be ruled out in sensitive persons. Sensitization through contact with skin/ mucous tissue is possible. | Both products include warnings about possible allergies. No other information is relevant to the comparison of the two products. | | | • Consult accompanying Safety Data Sheet (SDS). • Do not use after expiration date. ReminGel is not sterile and is not intended to be sterilized. Failure to follow | Keep out of reach for children. Do not use after the expiration date. Take the appropriate protective measures (e.g. wear gloves and safety glasses). | | 510k Summary Issued: 2026-09-03 Page 4 von 6 Rev. 3 {8} KETTENBACHVENTAL Simply intelligent | | Predicate Devices | Substantial Equivalent Device | Conclusion | | --- | --- | --- | --- | | Product | ReminGel® | Profisil® Free | | | Manufacturer | Inter-Med, Inc. / Vista Apex | Kettenbach GmbH & Co. KG | | | | these instructions could damage the product resulting in procedural delays or user inconvenience. | Avoid contact with the eyes. If there is accidental contact with the eyes: rinse immediately and thoroughly with an eye wash or water. Consult a medical doctor if problems arise or persist. Avoid contact with clothing, as permanent damage to clothes cannot be excluded. For hygienic reasons, the components are intended for single use only. Safety data sheets are available at www.kettenbach.com. | | | Shelf Life | 24 months | 24 months | The shelf life is identical. | | Sterility | Non-sterile | Non-sterile | Both products are non-sterile. | | Intended user | Rx and OTC | Rx | Both products must be used by qualified personnel (Rx). The predicate device is also approved for OTC use. | | Summary Finished Device Comparison | Profisil Free shares similar intended use, technical characteristics, and composition to the predicate device. Therefore, Profisil Free is substantially equivalent to the predicate device and poses not additionally safety or efficacy risks. | | | 510k Summary Issued: 2026-09-03 Rev. 3 Page 5 von 6 {9} KETTENBACHVENTAL Simply intelligent ### VII. Performance Data: Biocompatibility data have been provided for Profisil Free to assure biological safety in accordance with ISO 10993-1:2025, 'Biological Evaluation of medical devices Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process' as recognized by FDA. Data on tests in respect to cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), irritation (ISO 10993-23), material mediated pyrogenicity (ISO 10993-11), and acute systemic toxicity (ISO 10993-11) were conducted. Additionally bench testing was performed to allow an evaluation of the properties of Profisil Free and ReminGel (K241489/Predicate Device). #### Summary: The test showed that Profisil Free is considered biocompatible and comparable to other materials on the market. Therefore, no toxicological risks and resulting hazards for patients, users and third parties can be concluded. Clinical Performance Data: Data from clinical studies was not provided. ### VIII. Conclusion: Based on similarities in technology and indication Profisil \( ^{®} \) Free is considered substantially equivalent to the predicate device ReminGel \( ^{®} \) (K241489). 510k Summary Issued: 2026-09-03 Rev. 3 Page 6 von 6