Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 24, 2023 Kettenbach GmbH & Co. KG Katja Simon Regulatory Affairs Manager Im Heerfeld 7 Eschenburg, Hessen 35713 GERMANY Re: K230333 Trade/Device Name: Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: Class II Product Code: LBH Dated: June 22, 2023 Received: June 22, 2023 Dear Katja Simon: 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. {1}------------------------------------------------ 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 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 medical devices and radiation-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). Sincerelv. # Michael E. Adjodha -S 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 Ouality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. Submission Number (if known) K230333 Device Name Profisil Fluoride Varnish Combi pack (14801); Profisil Fluoride Varnish Normal pack mint (14802); Profisil Fluoride Varnish Normal pack berry (14804); Profisil Fluoride Varnish Normal pack unflavored (14806); Profisil Fluoride Varnish Sample pack (14800) Indications for Use (Describe) Profisil® Fluoride Varnish is a 5 % sodium fluoride varnish which 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 be 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for KETTENBACH DENTAL. The logo features a graphic of six circles arranged in a triangular shape, with the company name "KETTENBACH DENTAL" written in a sans-serif font below it. Underneath the company name, the tagline "Simply intelligent" is written in a smaller font. # 510(k) Summary - K230333 #### l. Submitter: Kettenbach GmbH & Co KG Im Heerfeld 7 35713 Eschenburg Germany Phone: +49 2774 705 0 Fax: +49 2774 705 66 ## Contact person: Simon, Katja Regulatory Affairs Manager Im Heerfeld 7 35713 Eschenburg Germany Phone: + 49 277 4705 0 E-mail: katja.simon@kettenbach.com ## Date of preparation: July 24th, 2023 ## II. Device Name of Device: Common or Usual Name: Classification Name: Regulatory Class: Product Code: Profisil® Fluoride Varnish Profisil® Fluoride Varnish Dental, Varnish, Cavity (21 CFR 872.3260) = LBH {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for KETTENBACH DENTAL. The logo consists of six blue circles arranged in a pyramid shape above the company name. Below the company name is the tagline "Simply intelligent". ## . Predicate devices: Vanish™ Varnish (3M Espe), K092141 This predicate has not been subject to a design-related recall. No reference devices were used in this submission. ### IV. Device Description: Profisil® Fluoride Varnish is designed to securely adhere to the tooth surface for several hours while releasing fluoride ions. The varnish contains 5 % sodium fluoride suspended in a mucosa-friendly, pleasantly flavored dimethicone gel. The varnish is available in following versions: mint, berry and unflavored. #### V. Indications for Use: Profisil® Fluoride Varnish is a 5 % sodium fluoride varnish which produces mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image features the logo for KETTENBACH DENTAL. The logo consists of a triangular arrangement of six blue circles above the text "KETTENBACH DENTAL", with the word "DENTAL" in a slightly lighter shade of blue. Below the company name is the tagline "Simply intelligent" in a smaller font size. ## Table 1: COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI. | | Predicate Devices | Substantial Equivalent Device | Conclusion | |------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product | Vanish Varnish | Profisil® | | | Manufacturer | 3M Espe | Kettenbach GmbH & Co. KG | | | Product<br>Description | 3M™ ESPE™ Vanish™ Varnish 5%<br>Sodium Fluoride White Varnish is a<br>22.600 ppm fluoride-containing varnish for<br>application to enamel and dentin for the<br>treatment of hypersensitivity teeth. It will<br>spread on and adhere to moist teeth.<br>Vanish varnish is an alcohol-based<br>solution of modified rosin. The product is<br>sweetened with xylitol. Vanish varnish<br>contains an innovative tri-calcium<br>phosphate (TCP) ingredient exclusively<br>from 3M. The ingredient TCP serves as a<br>source of bioavailable calcium and<br>phosphate ions when the varnish is<br>applied to the teeth. Calcium and<br>phosphate ions are naturally occurring<br>components of saliva long associated with<br>maintaining healthy teeth. | Profisil® Fluoride Varnish is designed to<br>securely adhere to the tooth surface for<br>several hours while releasing fluoride<br>ions. The varnish contains 5 % sodium<br>fluoride suspended in a mucosa-friendly,<br>pleasantly flavored dimethicone gel. The<br>varnish is available in following versions:<br>mint, berry and unflavored. | Treatment of<br>hypersensitivity teeth is the<br>technological principle for<br>both the subject and<br>predicate devices. The<br>content of sodium fluoride<br>is identical.<br>The following differences<br>exist between the subject<br>and the predicate device:<br>Profisil® does not contain<br>TCP | | Intended purpose | 5% Sodium Fluoride Varnish for the<br>treatment of dentinal hypersensitivity | 5% Sodium Fluoride Varnish indicated<br>for the treatment of dentinal<br>hypersensitivity. | The intended purpose is<br>identical | | Indication | • Treatment of hypersensitive teeth<br>• Use on exposed dentin and root<br>sensitivity<br>• Under temporary restoratives and<br>cements where post-operative sensitivity<br>is of concern | Profisil® Fluoride Varnish is a 5 %<br>sodium fluoride varnish which produces<br>mechanical occlusion of the dentinal<br>tubules in the treatment of tooth<br>hypersensitivity. | The indication is the same<br>and are intended for the<br>same general population of<br>patients, experiencing<br>dentinal hypersensitivity.<br>Both devices produce an<br>occlusion of the dentinal<br>tubules in the treatment of<br>tooth hypersensitivity. | | Basic formulation | • Colophony / Polyamide resin<br>• Ethyl alcohol<br>• Flavor<br>• 5% Sodium fluoride | • Silicone Encapsulant<br>• Thickener/ Adhesive<br>• Flavor / Sweetener<br>• 5% Sodium fluoride | The percentage of sodium<br>fluoride is identical.<br>However, Profisil does not<br>contain TCP | | | Predicate Devices | Substantial Equivalent Device | Conclusion | | Product | Vanish Varnish | Profisil® | | | Manufacturer | 3M Espe | Kettenbach GmbH & Co. KG | | | Mode of action /<br>technology | Dentin tubule occlusion<br>The material acts to physically block or<br>occlude patent/open dentin tubules on the<br>dentition. Vanish Varnish has unit-dose<br>packages delivering up to 0.25 mL to 0.4<br>mL of 5% sodium fluoride.<br>However, this product contains<br>substances that may cause an allergic<br>reaction by skin contact in certain<br>individuals. | Dentin tubule occlusion<br>The material acts to physically block or<br>occlude patent/open dentin tubules on<br>the dentition. | Same mode of action. | | Single use | Single use only | Single use only | Identical, both are single<br>use devices | | Method of<br>application | Unit-dose packages delivering up to 0.25<br>ml or 0.4ml of 5% sodium fluoride varnish.<br>Varnish and an applicator brush placed in<br>a molded tray and closed with a seal | Unit-dose packages delivering in 0.5ml<br>of 5% sodium fluoride varnish. Varnish<br>and an applicator brush placed in a<br>molded tray and closed with a seal | The delivery systems and<br>the mode of application are<br>similar. | | Contraindications /<br>Precautions | This product contains substances that<br>may cause an allergic reaction by skin<br>contact in certain individuals. Avoid use of<br>this product in patients with known<br>colophony allergies. Discontinue patient's<br>use of other prescriptive fluoride<br>preparations for 24 hours following Vanish<br>Varnish 5% sodium fluoride varnish<br>application. Children taking fluoride<br>supplements should discontinue for 1-3<br>days following treatment. | Do not use this product on any individual<br>who has a known intolerance to fluoride.<br>If any signs of inflammation or allergic<br>reaction occur, discontinue use<br>immediately and refrain from further use<br>with this patient.<br>Other prescription products containing<br>fluoride should not be used within 24<br>hours of using the varnish.<br>Patients using regular, systemic<br>fluoridation should stop using these<br>products for three days following use of<br>this varnish | Discontinue patient's use of<br>other prescriptive fluoride<br>preparations for 24 hours /<br>three days is similar | | Shelf Life | 24 months | 24 months | The shelf life is identical | | Performance<br>testing | A comparison of the parameters in respect, pH value, dynamic viscosity, fluoride release and electron microscopy<br>(SEM) studies were performed. The results demonstrated the substantial equivalence to the predicate device. | | | | Summary of<br>Product<br>Description, | The indication of the subject device is the same for the predicate device. Contraindications, application, and side<br>effects for both products are basically the same - there is a slight difference in the wording. | | | | | Predicate Devices | Substantial Equivalent Device | Conclusion | | Product | Vanish Varnish | Profisil® | | | Manufacturer | 3M Espe | Kettenbach GmbH & Co. KG | | | Intended purpose<br>Indications,<br>Contraindications /<br>Precautions | | | | | Summary<br>Chemical<br>Composition | The Profisil® formulation has been thoroughly assessed for biocompatibility. | | | | Summary of<br>Finished<br>Device<br>Specification | According to EN ISO 17730:2020 "Dentistry - fluoride varnishes" apart from the total fluoride, no other properties<br>appear as being relevant for having the device functioning or performing as intended.<br>Specific physical properties have been assessed and verified according to product standard EN ISO 17730:2020 –<br>Dentistry- fluoride varnishes".<br>The acceptance criteria of EN ISO 17730:2020 was fulfilled. | | | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image features the logo for KETTENBACH DENTAL. Above the company name, there is a graphic of six circles arranged in a triangular pattern. Below the company name, the words "Simply intelligent" are written in a smaller font. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image features the logo for KETTENBACH DENTAL. The logo consists of six blue circles arranged in a triangular formation above the text "KETTENBACH DENTAL". Below the company name is the tagline "Simply intelligent" in a smaller font size. The overall design is clean and professional, suggesting a focus on innovation and simplicity. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for KETTENBACH DENTAL. The logo consists of a blue graphic of six circles arranged in a triangular shape above the company name. The text "KETTENBACH DENTAL" is written in blue, with the word "DENTAL" in a slightly lighter shade. Below the company name is the tagline "Simply intelligent" in a smaller, lighter blue font. ### VII. Performance Data: Biocompatibility: The following performance data were provided in support of the substantial equivalence determination. The biocompatibility evaluation for Profisil® Fluoride Varnish was conducted in accordance with ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.: - · Cytotoxicity ISO 10993-5 - · Sensitization ISO 10993-10 - Irritation ISO 10993-23 - Pyrogenicity ISO 10993-11 - · Systemic toxicity ISO 10993-11 To evaluate the biological safety of Kettenbach's Fluoride Varnish, consideration was given to the type of patient contact, the potential hazards associated with the chemicals used in the devices, and historical use of the materials used in the devices. Profisil® Fluoride Varnish is considered to have met the requirements of ISO 10993-1:2018, ISO 7405:2018, FDA's Use of International standard ISO 10993-1, and the European Union Medical Regulation (EU) 2017/745 is an externally communicating device with limited (<24 hours) contact with the patient's tissue/bone/dentin and can be considered safe for use. # Non-clinical performance: According to EN ISO 17730:2020 "Dentistry - fluoride varnishes" apart from the total fluoride, no other properties appear as being relevant for having the device functioning or performing as intended. Specific physical properties have been assessed and verified according to product standard EN ISO 17730:2020 - Dentistry- fluoride varnishes". The acceptance criteria of EN ISO 17730:2020 was fulfilled. - pH value - · Dynamic viscosity - · Fluoride release - · Electron microscopy (SEM) study Summary: Based on the performance data, Profisil® Fluoride Varnish was found to have a safety and effectiveness profile that is similar to the predicate device. Clinical Performance Data: Data from clinical studies was not provided. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image features the logo for KETTENBACH DENTAL. The logo consists of six blue circles arranged in a triangular formation above the text "KETTENBACH DENTAL", with "DENTAL" in a slightly lighter shade of blue. Below the company name is the tagline "Simply intelligent" in a smaller font size. # VIII. Conclusion: Kettenbach Profisil® Fluoride Varnish is comprised of a highly substantive and highly viscous dimethicone gel carrier containing a suspension of 5% sodium by weight sodium fluoride crystals. The material acts to physically block or occlude patent/open dentin tubules on the dentition. This is achieved by applying the sodium fluoride dimethicone gel with an applicator brush to the affected dentition. The gel is allowed to penetrate the porosity of the tooth structure and block these open pores. The sodium fluoride reacts with calcium to form insoluble calcium fluoride to create a semi-permanent occluding material to alleviate the effect of dentinal hypersensitivity. Profisil® Fluoride Varnish is substantially equivalent to the predicate device 3M Vanish Varnish in the indications for use and mechanism of action. Both products are intended for the reduction of dentinal hypersensitivity, and both produce this effect by the mechanical occlusion of the open dentinal tubules upon and within the dentition. Both Kettenbach Profisil® Fluoride Varnish and 3M Vanish Varnish are applied in an identical manner and are intended for the same general dental population. Laboratory data demonstrate both products are equivalent in efficacy and release fluoride at an equivalent rate.