(167 days)
Profisil® Fluoride Varnish is a 5 % sodium fluoride varnish which produces mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.
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.
The provided document describes a 510(k) premarket notification for a dental device, "Profisil Fluoride Varnish." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials for effectiveness. Therefore, the information typically requested about acceptance criteria and studies proving a device meets them for new effectiveness claims, especially those involving AI or comparative effectiveness with human readers, is not directly applicable to this specific submission.
However, the document does detail how the new device demonstrates equivalence to its predicate, focusing on non-clinical performance and biocompatibility. Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance
For "Profisil® Fluoride Varnish," the acceptance criteria for non-clinical performance are based on the international standard EN ISO 17730:2020 "Dentistry - fluoride varnishes."
| Performance Characteristic | Acceptance Criteria (EN ISO 17730:2020) | Reported Device Performance (Profisil® Fluoride Varnish) | Conclusion |
|---|---|---|---|
| pH value | Not explicitly stated, but within standard requirements | Assessed and verified against EN ISO 17730:2020 | Fulfilled |
| Dynamic viscosity | Not explicitly stated, but within standard requirements | Assessed and verified against EN ISO 17730:2020 | Fulfilled |
| Fluoride release | Not explicitly stated, but within standard requirements | Assessed and verified against EN ISO 17730:2020 | Fulfilled; equivalent rate to predicate |
| Electron microscopy (SEM) study | Not explicitly stated, but within standard requirements | Assessed and verified against EN ISO 17730:2020 | Fulfilled |
| Total Fluoride | Relevant for functioning as intended (EN ISO 17730:2020) | Contains 5% sodium fluoride (identical to predicate) | Equivalent |
Biocompatibility Acceptance Criteria:
| Test | Standard | Acceptance Criteria | Reported Device Performance (Profisil® Fluoride Varnish) |
|---|---|---|---|
| Cytotoxicity | ISO 10993-5 | Meets ISO 10993-5 requirements | Met requirements |
| Sensitization | ISO 10993-10 | Meets ISO 10993-10 requirements | Met requirements |
| Irritation | ISO 10993-23 | Meets ISO 10993-23 requirements | Met requirements |
| Pyrogenicity | ISO 10993-11 | Meets ISO 10993-11 requirements | Met requirements |
| Systemic toxicity | ISO 10993-11 | Meets ISO 10993-11 requirements | Met requirements |
2. Sample Size Used for the Test Set and Data Provenance
- Test set sample size: Not explicitly stated as this is a non-clinical device evaluation. The "test set" would refer to the samples of the Profisil® Fluoride Varnish subjected to the various physical and chemical tests (e.g., specific batches for pH, viscosity, fluoride release tests) and biocompatibility studies (e.g., cell cultures for cytotoxicity, animal models for sensitization/irritation). The exact number of samples tested for each property is not detailed in the summary.
- Data provenance: The standard EN ISO 17730:2020 is an international standard. Biocompatibility standards like ISO 10993 series are also international. The summary indicates these tests were performed to demonstrate compliance with these standards, suggesting laboratory testing specifically for the Profisil® product. There is no information on country of origin of data beyond the manufacturer being based in Germany. The data is prospective as it was generated to support the current submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The "ground truth" for this type of device comparison is based on established scientific and engineering principles codified in international standards (EN ISO 17730:2020 for dental fluoride varnishes) and biocompatibility standards (ISO 10993 series). The results are objectively measured physical and chemical properties and biological responses, not subjective interpretations by human experts in the sense of medical image analysis.
4. Adjudication Method for the Test Set
Not applicable, as the "test set" involves objective laboratory measurements against predefined standard requirements rather than subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
Not applicable. This device is a dental fluoride varnish, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable for the same reason as above; this is a physical dental material, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the current device's performance evaluation is based on International Standards:
- EN ISO 17730:2020 "Dentistry - fluoride varnishes" for physical and chemical properties (pH, dynamic viscosity, fluoride release, SEM).
- ISO 10993 series for biocompatibility studies (cytotoxicity, sensitization, irritation, pyrogenicity, systemic toxicity).
These standards define the acceptable range or nature of results for these properties, which serve as the objective "ground truth" for evaluation.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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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.
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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
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
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)
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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
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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.
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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 | |
| ProductDescription | 3M™ ESPE™ Vanish™ Varnish 5%Sodium Fluoride White Varnish is a22.600 ppm fluoride-containing varnish forapplication to enamel and dentin for thetreatment of hypersensitivity teeth. It willspread on and adhere to moist teeth.Vanish varnish is an alcohol-basedsolution of modified rosin. The product issweetened with xylitol. Vanish varnishcontains an innovative tri-calciumphosphate (TCP) ingredient exclusivelyfrom 3M. The ingredient TCP serves as asource of bioavailable calcium andphosphate ions when the varnish isapplied to the teeth. Calcium andphosphate ions are naturally occurringcomponents of saliva long associated withmaintaining healthy teeth. | Profisil® Fluoride Varnish is designed tosecurely adhere to the tooth surface forseveral hours while releasing fluorideions. The varnish contains 5 % sodiumfluoride suspended in a mucosa-friendly,pleasantly flavored dimethicone gel. Thevarnish is available in following versions:mint, berry and unflavored. | Treatment ofhypersensitivity teeth is thetechnological principle forboth the subject andpredicate devices. Thecontent of sodium fluorideis identical.The following differencesexist between the subjectand the predicate device:Profisil® does not containTCP |
| Intended purpose | 5% Sodium Fluoride Varnish for thetreatment of dentinal hypersensitivity | 5% Sodium Fluoride Varnish indicatedfor the treatment of dentinalhypersensitivity. | The intended purpose isidentical |
| Indication | • Treatment of hypersensitive teeth• Use on exposed dentin and rootsensitivity• Under temporary restoratives andcements where post-operative sensitivityis of concern | Profisil® Fluoride Varnish is a 5 %sodium fluoride varnish which producesmechanical occlusion of the dentinaltubules in the treatment of toothhypersensitivity. | The indication is the sameand are intended for thesame general population ofpatients, experiencingdentinal hypersensitivity.Both devices produce anocclusion of the dentinaltubules in the treatment oftooth hypersensitivity. |
| Basic formulation | • Colophony / Polyamide resin• Ethyl alcohol• Flavor• 5% Sodium fluoride | • Silicone Encapsulant• Thickener/ Adhesive• Flavor / Sweetener• 5% Sodium fluoride | The percentage of sodiumfluoride is identical.However, Profisil does notcontain TCP |
| Predicate Devices | Substantial Equivalent Device | Conclusion | |
| Product | Vanish Varnish | Profisil® | |
| Manufacturer | 3M Espe | Kettenbach GmbH & Co. KG | |
| Mode of action /technology | Dentin tubule occlusionThe material acts to physically block orocclude patent/open dentin tubules on thedentition. Vanish Varnish has unit-dosepackages delivering up to 0.25 mL to 0.4mL of 5% sodium fluoride.However, this product containssubstances that may cause an allergicreaction by skin contact in certainindividuals. | Dentin tubule occlusionThe material acts to physically block orocclude patent/open dentin tubules onthe dentition. | Same mode of action. |
| Single use | Single use only | Single use only | Identical, both are singleuse devices |
| Method ofapplication | Unit-dose packages delivering up to 0.25ml or 0.4ml of 5% sodium fluoride varnish.Varnish and an applicator brush placed ina molded tray and closed with a seal | Unit-dose packages delivering in 0.5mlof 5% sodium fluoride varnish. Varnishand an applicator brush placed in amolded tray and closed with a seal | The delivery systems andthe mode of application aresimilar. |
| Contraindications /Precautions | This product contains substances thatmay cause an allergic reaction by skincontact in certain individuals. Avoid use ofthis product in patients with knowncolophony allergies. Discontinue patient'suse of other prescriptive fluoridepreparations for 24 hours following VanishVarnish 5% sodium fluoride varnishapplication. Children taking fluoridesupplements should discontinue for 1-3days following treatment. | Do not use this product on any individualwho has a known intolerance to fluoride.If any signs of inflammation or allergicreaction occur, discontinue useimmediately and refrain from further usewith this patient.Other prescription products containingfluoride should not be used within 24hours of using the varnish.Patients using regular, systemicfluoridation should stop using theseproducts for three days following use ofthis varnish | Discontinue patient's use ofother prescriptive fluoridepreparations for 24 hours /three days is similar |
| Shelf Life | 24 months | 24 months | The shelf life is identical |
| Performancetesting | A comparison of the parameters in respect, pH value, dynamic viscosity, fluoride release and electron microscopy(SEM) studies were performed. The results demonstrated the substantial equivalence to the predicate device. | ||
| Summary ofProductDescription, | The indication of the subject device is the same for the predicate device. Contraindications, application, and sideeffects 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 purposeIndications,Contraindications /Precautions | |||
| SummaryChemicalComposition | The Profisil® formulation has been thoroughly assessed for biocompatibility. | ||
| Summary ofFinishedDeviceSpecification | According to EN ISO 17730:2020 "Dentistry - fluoride varnishes" apart from the total fluoride, no other propertiesappear 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. |
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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.
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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.
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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.
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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.
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.