(256 days)
For treatment of dentinal hypersensitivity secondary to exposed dentin and root cervical surfaces.
Cervitec®F is a dental varnish for the treatment of dentinal hypersensitivity secondary to exposed dentin and root cervical surfaces. The varnish system is characterized by its good moisture tolerance during application. Cervited in either a Tube (4gm, 7gm) or Single Dose (0.26gm) delivery form.
The provided document describes the substantial equivalence of the Cervitec F dental varnish to its predicate devices, primarily Fluor Protector S (K131487), based on non-clinical performance testing and biocompatibility assessments. It does not contain information about a study proving the device meets acceptance criteria related to its clinical efficacy in treating dentinal hypersensitivity or exposed dentin and root cervical surfaces using metrics typically found in medical device studies (e.g., sensitivity, specificity, AUC).
Instead, the acceptance criteria and supporting study are focused on demonstrating that Cervitec F adheres to a relevant standard for fluoride varnishes and is biocompatible.
Here's a breakdown of the information available based on your request:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (from EN ISO 17730:2014) | Reported Device Performance (Cervitec® F) |
|---|---|
| Total fluoride content shall not deviate by more than 20% from the stated amount on the package. | Fulfilled. The product complies with the requirements as defined by ISO 17730:2014, including the total fluoride content criteria. |
| Other properties relevant for the device functioning or performing as intended (as per ISO 17730:2014). | "Specific physical properties have been assessed and verified according to product standard EN ISO 17730:2014 - Dentistry- fluoride varnishes." (Implied compliance) |
| Biocompatibility (as per EN ISO 10993-1:2009 and EN ISO 7405:2008) - Non-cytotoxic | Is neither cytotoxic. |
| Biocompatibility - Not of acute or subchronic systemic toxicity | Is not of acute or subchronic systemic toxicity. |
| Biocompatibility - Not genotoxic | Is not genotoxic. |
| Biocompatibility - Does not induce oral mucosal irritation | Does not induce oral mucosal irritation. |
| Biocompatibility - Low sensitization potential | Has a low sensitization potential. |
2. Sample size used for the test set and the data provenance:
- Non-clinical performance testing (ISO 17730:2014): Not explicitly stated. The document mentions "Specific physical properties have been assessed and verified," but details on the number of samples or methodology are not provided. These are generally laboratory tests on product batches.
- Biocompatibility testing: Not explicitly stated. Biocompatibility tests usually involve in vitro assays and in vivo animal studies, but the number of samples or subjects is not mentioned.
The provenance of this data is internal testing conducted by the manufacturer, Ivoclar Vivadent AG, to demonstrate compliance with international standards. It's retrospective in the sense that these tests were performed to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. The "ground truth" for the non-clinical performance and biocompatibility refers to the established standards (ISO 17730:2014, EN ISO 10993-1:2009, EN ISO 7405:2008) themselves, and the device's adherence to their requirements as measured through laboratory and biological tests. There are no human "experts" establishing a clinical ground truth for image interpretation or diagnosis in this context.
4. Adjudication method for the test set:
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices where human reader interpretations are compared. This document describes non-clinical and biocompatibility testing.
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:
No. This type of study (MRMC, AI assistance) is not mentioned and is not relevant for a dental varnish approval for dentinal hypersensitivity. The device is a direct treatment, not a diagnostic or AI-powered assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a manual application dental varnish, not an algorithm.
7. The type of ground truth used:
- For non-clinical performance: The ground truth is defined by the specifications set out in the international standard EN ISO 17730:2014 "Dentistry – fluoride varnishes," particularly regarding the total fluoride content.
- For biocompatibility: The ground truth is established by the accepted scientific and regulatory principles for biocompatibility testing as outlined in EN ISO 10993-1:2009 and EN ISO 7405:2008, determining whether the material elicits an adverse biological response.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI-driven device, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
Not applicable, as there is no training set.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
February 11, 2020
Ivoclar Vivadent, AG % Lori Aleshin Director of Quality & Regulatory Affairs Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst, New York 14228
Re: K191453
Trade/Device Name: Cervitec F Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: Class II Product Code: LBH Dated: January 10, 2020 Received: January 14, 2020
Dear Ms. Lori Aleshin:
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.
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
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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 (OS) 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 mediation-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).
Sincerely,
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191453
Device Name Cervitec® F
Indications for Use (Describe)
For treatment of dentinal hypersensitivity secondary to exposed dentin and root cervical surfaces.
| 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 Ivoclar Vivadent. The logo is in blue and green, with the words "Ivoclar Vivadent" in a bold, sans-serif font. Above the words is a series of green and blue dots and squares arranged in an arc. Below the words is the tagline "passion vision innovation" in a smaller, sans-serif font.
K191453
| Contact: | Lori Aleshin, Director of Quality & Regulatory Affairs IvoclarVivadent, Inc.175 Pineview Drive Amherst,New York 14228 716-691-2045lori.aleshin@ivoclarvivadent.com | |
|---|---|---|
| Company: | Ivoclar Vivadent, AGBendererstrasse 2, Schaan, FL-9494, Liechtenstein+423-235-3535 | |
| Date Prepared: | February 10, 2020 | |
| Proprietary Name: | Cervitec® F | |
| Classification Name: | Dental, Varnish, Cavity (872.3260)(Classification Code LBH) | |
| Device Class and panel: | Class 2- dental | |
| Primary Predicate: | Fluor Protector S (K131487) by Ivoclar Vivadent, AG | |
| Reference Device: | Cervitec Plus (K072338) by Ivoclar Vivadent, AG | |
| Reference Device: | Biotene Mouthspray (K103745) by GlaxoSmithKline ConsumerHealthcare |
Device Description: Cervitec®F is a dental varnish for the treatment of dentinal hypersensitivity secondary to exposed dentin and root cervical surfaces. The varnish system is characterized by its good moisture tolerance during application. Cervited in either a Tube (4gm, 7gm) or Single Dose (0.26gm) delivery form.
Intended Use:
Cervitec F is applied by the dentist, dental prophylaxis assistants or professionally instructed personnel. Cervitec F is suitable for all age groups.
Indications for Use:
For treatment of dentinal hypersensitivity secondary to exposed dentin and root cervical surfaces.
Comparison to Predicate:
The primary predicate devices to which Cervitec®F has been compared is Ivoclar Vivadent's Fluor Protector S (K131487)
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Image /page/4/Picture/1 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in a bold, blue font, with the words "passion vision innovation" written in a smaller font below. Above the company name, there is a series of green and blue dots and squares arranged in an arc shape.
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Substantial Equivalence to the predicate and reference devices:
| Device | Primary PredicateDevice:Fluor Protector S(K131487) | Reference Device:Cervitec Plus (K072338) | Reference Device: BioteneMouthspray (K103745) | Subject Device: Cervitec® F(K191453) | |
|---|---|---|---|---|---|
| Manufacturer | Ivoclar Vivadent AG | Ivoclar Vivadent AG | Glaxosmithkline ConsumerHealthcare | Ivoclar Vivadent AG | |
| Indications for Use | Fluor Protector S is aprotective fluoride varnish fortooth desensitization.- Treatment of dentinalhypersensitivity- Treatment of exposedcervicals- Treatment of sensitivityafter tooth whitening | Cervitec Plus is a dental varnishmaterial that is used for theprotection of exposed root surfacesand treatment of hypersensitivecervicals | Relieves the symptoms of dry mouth;refreshes, moisturizes, sooths oralirritation, and lubricates oral dryness. | For treatment of dentinalhypersensitivity secondary to exposeddentin and root cervical surfaces. | |
| PrecautionMeasures/Contraindications/Processingrestrictions/ Sideeffects | ContraindicationIf patients are known to beallergic to any of theingredients of Fluor ProtectorS, the material should not beused.ApplicationFluor Protector S is applied bydentists and dentalprofessionals. Fluor Protector Sis suitable for treating patientsof all ages.Side effectsA slight temporary burningsensation may occur if theproduct comes in contact withthe mucous membrane. | ContraindicationIf patients are known to be allergic toany of the ingredients in Cervitec Plus,the material should not be applied.ApplicationCervitec Plus can be used for patientsof all age groups and is professionallyapplied by dentists, dental hygienistsor dental prophylaxis assistants.Generally, Cervitec Plus is appliedevery three months. If intensivetreatment is required, however, thevarnish may also be applied morefrequently. One Free Stand SingleDose Cervitec Plus is enough for thetreatment of one set of teeth. Onetube is enough for about 20-30 setsof teeth. | No information available | ContraindicationIf users are known to be allergic to anyof the ingredients in Cervitec F, thematerial should not be applied.ApplicationCervitec F is applied by the dentist,dental hygienists, dental prophylaxisassistants or professionally instructedpersonnel. Cervitec F is suitable for allage groups.Side effectsContact with the mucous membranemay result in short term, reversibleirritation.Chlorhexidine may cause reversiblediscoloration of thetooth structure andrestorations. In rare, isolated cases,chlorhexidine may cause allergicreactions. | |
| WarningIn rare, isolated cases, chlorhexidine may cause allergic reactions.Side effectsIn individual cases, contact with the mucous membrane may result in short-term, reversible irritation.Chlorhexidine may cause reversible discoloration of the tooth structure and restorations. | |||||
| Summary ofIndications,PrecautionMeasures/Contraindications/Processingrestrictions/Side effects | The indications for the subject device are the same as for the predicate Fluor Protector S (the predicate has an additional one). Contraindications, application and side effects for both products are basically the same – there is a slight difference in the wording. The note for Chlorhexidine (side effect) is new – the predicate did not contain this component. | ||||
| Technology | Fluor Protector S is a protective varnish containing fluoride. Its purpose is the treatment of dentinal hypersensitivity, exposed cervicals and sensitivity after tooth whitening. Ethanol and water are the organic solvents. Fluoride ions lead to precipitation of calcium fluoride; this is an additional mechanism, which provides blockage and protection of exposed dentin tubules. | Cervitec Plus is a varnish that protects sensitive dentin in the case of exposed cervicals. Chlorhexidine and thymol are the antimicrobial components in Cervitec Plus. They protect the tooth surface by reducing bacterial activity. | Biotene Moisturizing Mouth Spray for Dry Mouth Symptom Relief is a specially formulated artificial saliva substitute, which contains moisturizers, humectants, a protein, and a patented salivary enzymes that collectively have lubricating, moisturizing, soothing, and refreshing properties to relieve & treat the symptoms of dry mouth. | Cervitec F contains fluoride in a varnish base. The varnish contains chlorhexidine and cetylpyridinium chloride and has a good moisture tolerance during application. Ethanol and water are the organic solvents. Fluoride ions lead to precipitation of calcium fluoride; this is an additional mechanism, which provides blockage and protection of exposed dentin tubules. | |
| Summary ofTechnology | Even though the chemical composition is slightly different in both the predicate and subject device varnishes, the result is a thin, transparent layer-providing blockage of the dentinal tubules, the main working principle of the product. | ||||
| Delivery forms/dosage | Tube of liquid 4g Tubeof liquid 7g Single dose0.26g | Single dose Multidose | 1.5 oz non-pressurized pump action spraybottle fitted with cap | Tube of liquid 4g Tubeof liquid 7g Single dose0.26g | |
| Summary ofDeliveryforms/dosage | No difference between the predicate and proposed devices. | ||||
| Storage Conditions | 36 months at 2-28 °C / 36-82 °F | 2-8 °C | No information available | 36 months at 2-28 °C / 36-82 °F | |
| Summary ofStorage Conditions | The shelf life and the storage conditions are the same as for the predicate device Fluor Protector S. | ||||
| Principles ofOperation | Step-by-step:- Clean the tooth surfaces.- Create a dry working fieldwith cotton rolls, cotton woolwads and a saliva ejector orair syringe if necessary.- a) Single dose units: Peelthe foil top from the singledose unit; apply the varnishdirectly from the single doseunit.- b) Dispensing tube:Place the required amountin a dappen dish or similarvessel and close the tube.- Apply a thin layer with thehelp of a Vivabrush G.- Let the varnish dry for oneminute; thereafter, removethe cotton rolls.- After the treatment, askthe patient to spit out thecontents of the mouthwithout rinsing.Tips for patients: patientsshould refrain from eatingand drinking for one hourafter the treatment withFluor Protector S. | Step-by-step:1. Clean tooth surfacesthoroughly.2. Dry with cotton rolls and airsyringe.3. a) Single Dose:Remove the foil from the SingleDose and apply the varnishdirectly from the Single Dose.b) Tube:Press out 3 drops into, forexample, a dappen dish andreseal the tube.Hold the tube in a vertical positionwith the cap facing upwards foropening and closing. For pressingout the contents, hold the openingvertically down.4. Apply a thin coat of varnish bymeans of a Vivadent applicator orsuitable brush (diagram); inproximal areas, Cervitec Plus isapplied with dental floss.5. Let the varnish dry. Thevarnish can be dispersed with air.6. Remove cotton rolls after 30seconds.7. Ask patients not to rinse theirmouth. | Method of Use: Ready to use sprayApplications per Day: As needed | Step-by-step:- Clean the tooth surfaces.- Isolate the application area withcotton rolls and cotton swabs.- The use of a saliva ejector or airsyringe is optional.- a) Single Dose unit: Remove thefoil from the Single Dose and applythe varnish directly from the SingleDose.- b) Dosing tube: Dispense therequired amount into e.g. a dappendish and close the tube again.- Apply the varnish in a thin layerusing e.g. Vivabrush G.- Allow the varnish to dry for 1minute and then remove the cottonrolls.- No rinsing after application, onlyspitting.Eating and drinking should beavoided for 1 hour after applicationof Cervitec F.Vivabrush G is a class I medicaldevice - therefore no 510(k) required | |
| Summary Principlesof operation | There are slight differences in the wording between the predicate and proposed device for the application, but the steps are basically the same. | ||||
| Composition | Acrylate copolymer | VA/Crotonates Copolymer andChlorhexidine diacetate (CHX) | Cetylpyridinium chloride (CPC) | VA/Crotonates Copolymer,Chlorhexidine diacetate (CHX) andCetylpyridinium chloride (CPC) | |
| Summary ChemicalComposition | The chemical composition slightly differs between the two devices to meet customer needs (improved moisture tolerance).The subject device formulation has been thoroughly assessed for biocompatibility and the result of the Biocompatibility Assessment of Cervitec F issubstantially equivalent to the results for the predicate device. See attached Biocompatibility Assessment. | ||||
| Finished DeviceSpecification | Applicable standard: ISO17730:2014- Dentistry –Fluoride varnishes | No information available | No information available | Applicable standard: ISO17730:2014- Dentistry -Fluoride varnishes | |
| Sterilization | Not applicable. No sterilizationrecommendation. | Not applicable. No sterilizationrecommendation. | Non-sterile | Not applicable. No sterilizationrecommendation. | |
| Single use | Consumable material | Single use only | No information available | Consumable material | |
| Summary of FinishedDevice Specification | According to EN ISO 17730:2014 "Dentistry – fluoride varnishes" apart from the total fluoride content (the total fluoride content shall not deviateby more than 20% from the stated amount on the package), no other properties appear as being relevant for having the device functioning orperforming as intended.Specific physical properties have been assessed and verified according to product standard EN ISO 17730:2014 - Dentistry- fluoride varnishes".The acceptance criteria of EN ISO 17730:2014 (the total fluoride content shall not deviate by more than 20% from the stated amount on thepackage) was fulfilled. | ||||
| Summary ofPerformanceSpecification | The performance is limited to the mechanical protection of hyper-sensitive teeth and exposed cervicals. |
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Image /page/6/Picture/0 description: The image shows the Ivoclar Vivadent logo, which is a dental company. The logo is blue and green, and it has the company name in a stylized font. There is also the number 4 on the right side of the logo.
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Image /page/7/Picture/0 description: The image shows the Ivoclar Vivadent logo with the words "passion vision innovation" underneath. The logo is blue and green, and there are some blue and green dots above the logo. The number 5 is in the upper right corner of the image.
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Image /page/8/Picture/1 description: The image contains the logo for Ivoclar Vivadent, a dental company. The logo features the company name in a stylized font, with "Ivoclar" in a darker blue and "Vivadent" in a lighter blue. Above the company name is a series of green and blue dots arranged in an arc. Below the company name is the tagline "passion vision innovation" in a smaller font.
Differences:
The chemical composition slightly differs between the predicate device and Cervitec F to meet customer needs (improved moisture tolerance). The differences between the submission device and the predicates do not raise concerns of safety and effectiveness for the submission device in comparison to the predicate devices.
Substantial Equivalence to the predicate and reference devices conclusion:
Both devices, the predicate device Fluor Protector S and the subject device Cervitec F are indicated for the protection of tooth structure by forming a protective varnish layer. In both cases, fluoride, a common agent in dental care products, enhances the mechanical protective effect.
Although the chemical formulation of Cervitec F is slightly different to the predicate device, the performance, function and biocompatibility remain the same. The biocompatibility of the subject device formulation was assessed and is equivalent to Fluor Protector S. The storage stability of the subject device formulation was assessed and is equivalent to Fluor Protector S. Therefore, Cervitec F is substantially equivalent to the predicate device, Fluor Protector S.
The reference devices were selected based on the chemical compositions; although slightly different, they do contain some of the same ingredients. This information is helpful in demonstrating substantial equivalence of the proposed device to its predicate.
Cervitec F contains VA/Crotonates Copolymer and Chlorhexidine diacetate (CHX), which are also included in Ivoclar Vivadent's Cervitec Plus cleared in 510(k) K072338 (reference device).
According to the appropriate Safety Data Sheet, Cetylpyridinium chloride (CPC) is also included in the following product of GlaxoSmithKline: the reference device Biotene Mouthspray cleared in 510(k): K103745 (Safety Data Sheet attached). Cetylpvridinium chloride (CPC) is used in Cervitec F.
Additionally, the components Alcohol, Aqua, Ammonium Fluoride, Peppermint aroma and Saccharin are found in the predicate device Fluor Protector S and in the proposed device Cervitec F.
Non-clinical performance testing:
According to EN ISO 17730:2014 "Dentistry - fluoride varnishes" apart from the total content (the total fluoride content shall not deviate by more than 20% from the stated amount on the package), no other properties appear as being relevant for having the device functioning or performing as intended. The Finished Device Specification confirms the product complies with the requirements as defined by ISO 17730:2014.
Biocompatibility:
Biocompatibility has been assessed according EN ISO 10993-1:2009 and EN ISO 7405:2008 and resulted in the following conclusions:
- Cervitec F is neither cytotoxic nor of acute or subchronic systemic toxicity.
- Cervitec F is not genotoxic
- Cervitec F does not induce oral mucosal irritation
- Cervitec F has a low sensitization potential
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Image /page/9/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo consists of the company name in two lines, with "Ivoclar" in green and "Vivadent" in blue. Above the company name is a curved line of green and blue dots. Below the company name is the company slogan, "passion vision innovation".
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Based on the toxicological evaluation of the product, clinical studies of the product, research literature supporting the biocompatibility of Cervitec F and the longstanding worldwide clinical use of similar materials, it can be concluded that the benefits provided by the final product exceed any potential risks produced by constituent device materials, providing that the instructions for use have been followed. This supports the biocompatibility of the predicate device.
The subject device was not tested or evaluated for EMC, Software, animal and sterility validation as they are not applicable.
Conclusion:
The data show that Cervitec® F is substantially equivalent to the primary predicate device, Fluor Protector S (K131487) .
§ 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.