Cervitec F

K191453 · Ivoclar Vivadent, AG · LBH · Feb 11, 2020 · Dental

Device Facts

• Record ID: K191453
• Device Name: Cervitec F
• Applicant: Ivoclar Vivadent, AG
• Product Code: LBH · Dental
• Decision Date: Feb 11, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For treatment of dentinal hypersensitivity secondary to exposed dentin and root cervical surfaces.

Device Story

Cervitec F is a dental varnish for treating dentinal hypersensitivity; applied by dentists, dental hygienists, or prophylaxis assistants. Device contains fluoride, chlorhexidine diacetate, and cetylpyridinium chloride in a varnish base with ethanol and water solvents. Principle of operation involves applying a thin layer to exposed dentin/root surfaces; varnish dries to form a protective layer that blocks dentinal tubules; fluoride ions precipitate as calcium fluoride to enhance mechanical protection. Applied in clinic setting; requires isolation of area with cotton rolls; varnish dries for one minute; patient instructed not to rinse. Benefits include reduced sensitivity of exposed root surfaces. Device is a consumable material supplied in tubes or single-dose units.

Clinical Evidence

No clinical data. Evidence based on bench testing per ISO 17730:2014 (fluoride content verification) and biocompatibility assessment per ISO 10993-1:2009 and ISO 7405:2008. Biocompatibility testing confirmed no cytotoxicity, no systemic toxicity, no genotoxicity, no oral mucosal irritation, and low sensitization potential.

Technological Characteristics

Dental varnish containing fluoride, chlorhexidine diacetate, and cetylpyridinium chloride in a VA/Crotonates Copolymer base. Solvents: ethanol and water. Form factor: liquid in tubes (4g, 7g) or single-dose units (0.26g). Complies with ISO 17730:2014 (Dentistry – fluoride varnishes). Non-sterile, consumable material.

Indications for Use

Indicated for treatment of dentinal hypersensitivity secondary to exposed dentin and root cervical surfaces in patients of all age groups.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Fluor Protector S (K131487)

Reference Devices

• Cervitec Plus (K072338)
• Biotene Mouthspray (K103745)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 10pt;">☐</span> 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 Ivoclar<br>Vivadent, Inc.<br>175 Pineview Drive Amherst,<br>New York 14228 716-691-<br>2045<br>[e-mail] | |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Company: | Ivoclar Vivadent, AG<br>Bendererstrasse 2, Schaan, FL-9494, Liechtenstein<br>[phone] | |
| Date Prepared: | February 10, 2020 | |
| Proprietary Name: | Cervitec® F | |
| Classification Name: | Dental, Varnish, Cavity (872.3260)<br>(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 Consumer<br>Healthcare | |

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 Predicate<br>Device:<br>Fluor Protector S<br>(K131487) | Reference Device:<br>Cervitec Plus (K072338) | Reference Device: Biotene<br>Mouthspray (K103745) | Subject Device: Cervitec® F<br>(K191453) | |
|----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Manufacturer | Ivoclar Vivadent AG | Ivoclar Vivadent AG | Glaxosmithkline Consumer<br>Healthcare | Ivoclar Vivadent AG | |
| Indications for Use | Fluor Protector S is a<br>protective fluoride varnish for<br>tooth desensitization.<br>- Treatment of dentinal<br>hypersensitivity<br>- Treatment of exposed<br>cervicals<br>- Treatment of sensitivity<br>after tooth whitening | Cervitec Plus is a dental varnish<br>material that is used for the<br>protection of exposed root surfaces<br>and treatment of hypersensitive<br>cervicals | Relieves the symptoms of dry mouth;<br>refreshes, moisturizes, sooths oral<br>irritation, and lubricates oral dryness. | For treatment of dentinal<br>hypersensitivity secondary to exposed<br>dentin and root cervical surfaces. | |
| Precaution<br>Measures/<br>Contraindications/<br>Processing<br>restrictions/ Side<br>effects | Contraindication<br>If patients are known to be<br>allergic to any of the<br>ingredients of Fluor Protector<br>S, the material should not be<br>used.<br>Application<br>Fluor Protector S is applied by<br>dentists and dental<br>professionals. Fluor Protector S<br>is suitable for treating patients<br>of all ages.<br>Side effects<br>A slight temporary burning<br>sensation may occur if the<br>product comes in contact with<br>the mucous membrane. | Contraindication<br>If patients are known to be allergic to<br>any of the ingredients in Cervitec Plus,<br>the material should not be applied.<br>Application<br>Cervitec Plus can be used for patients<br>of all age groups and is professionally<br>applied by dentists, dental hygienists<br>or dental prophylaxis assistants.<br>Generally, Cervitec Plus is applied<br>every three months. If intensive<br>treatment is required, however, the<br>varnish may also be applied more<br>frequently. One Free Stand Single<br>Dose Cervitec Plus is enough for the<br>treatment of one set of teeth. One<br>tube is enough for about 20-30 sets<br>of teeth. | No information available | Contraindication<br>If users are known to be allergic to any<br>of the ingredients in Cervitec F, the<br>material should not be applied.<br>Application<br>Cervitec F is applied by the dentist,<br>dental hygienists, dental prophylaxis<br>assistants or professionally instructed<br>personnel. Cervitec F is suitable for all<br>age groups.<br>Side effects<br>Contact with the mucous membrane<br>may result in short term, reversible<br>irritation.<br>Chlorhexidine may cause reversible<br>discoloration of thetooth structure and<br>restorations. In rare, isolated cases,<br>chlorhexidine may cause allergic<br>reactions. | |
| | | | | | |
| | | <b>Warning</b><br>In rare, isolated cases, chlorhexidine may cause allergic reactions.<br><b>Side effects</b><br>In individual cases, contact with the mucous membrane may result in short-term, reversible irritation.<br>Chlorhexidine may cause reversible discoloration of the tooth structure and restorations. | | | |
| Summary of<br>Indications,<br>Precaution<br>Measures/<br>Contraindications/<br>Processing<br>restrictions/<br>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 of<br>Technology | 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 Tube<br>of liquid 7g Single dose<br>0.26g | Single dose Multi<br>dose | 1.5 oz non-pressurized pump action spray<br>bottle fitted with cap | Tube of liquid 4g Tube<br>of liquid 7g Single dose<br>0.26g | |
| Summary of<br>Delivery<br>forms/dosage | No difference between the predicate and proposed devices. | | | | |
| Storage Conditions | 36 months at 2-28 °C / 36-<br>82 °F | 2-8 °C | No information available | 36 months at 2-28 °C / 36-82 °F | |
| Summary of<br>Storage Conditions | | The shelf life and the storage conditions are the same as for the predicate device Fluor Protector S. | | | |
| Principles of<br>Operation | Step-by-step:<br>- Clean the tooth surfaces.<br>- Create a dry working field<br>with cotton rolls, cotton wool<br>wads and a saliva ejector or<br>air syringe if necessary.<br>- a) Single dose units: Peel<br>the foil top from the single<br>dose unit; apply the varnish<br>directly from the single dose<br>unit.<br>- b) Dispensing tube:<br>Place the required amount<br>in a dappen dish or similar<br>vessel and close the tube.<br>- Apply a thin layer with the<br>help of a Vivabrush G.<br>- Let the varnish dry for one<br>minute; thereafter, remove<br>the cotton rolls.<br>- After the treatment, ask<br>the patient to spit out the<br>contents of the mouth<br>without rinsing.<br>Tips for patients: patients<br>should refrain from eating<br>and drinking for one hour<br>after the treatment with<br>Fluor Protector S. | Step-by-step:<br>1. Clean tooth surfaces<br>thoroughly.<br>2. Dry with cotton rolls and air<br>syringe.<br>3. a) Single Dose:<br>Remove the foil from the Single<br>Dose and apply the varnish<br>directly from the Single Dose.<br>b) Tube:<br>Press out 3 drops into, for<br>example, a dappen dish and<br>reseal the tube.<br>Hold the tube in a vertical position<br>with the cap facing upwards for<br>opening and closing. For pressing<br>out the contents, hold the opening<br>vertically down.<br>4. Apply a thin coat of varnish by<br>means of a Vivadent applicator or<br>suitable brush (diagram); in<br>proximal areas, Cervitec Plus is<br>applied with dental floss.<br>5. Let the varnish dry. The<br>varnish can be dispersed with air.<br>6. Remove cotton rolls after 30<br>seconds.<br>7. Ask patients not to rinse their<br>mouth. | Method of Use: Ready to use spray<br>Applications per Day: As needed | Step-by-step:<br>- Clean the tooth surfaces.<br>- Isolate the application area with<br>cotton rolls and cotton swabs.<br>- The use of a saliva ejector or air<br>syringe is optional.<br>- a) Single Dose unit: Remove the<br>foil from the Single Dose and apply<br>the varnish directly from the Single<br>Dose.<br>- b) Dosing tube: Dispense the<br>required amount into e.g. a dappen<br>dish and close the tube again.<br>- Apply the varnish in a thin layer<br>using e.g. Vivabrush G.<br>- Allow the varnish to dry for 1<br>minute and then remove the cotton<br>rolls.<br>- No rinsing after application, only<br>spitting.<br>Eating and drinking should be<br>avoided for 1 hour after application<br>of Cervitec F.<br>Vivabrush G is a class I medical<br>device - therefore no 510(k) required | |
| Summary Principles<br>of 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 and<br>Chlorhexidine diacetate (CHX) | Cetylpyridinium chloride (CPC) | VA/Crotonates Copolymer,<br>Chlorhexidine diacetate (CHX) and<br>Cetylpyridinium chloride (CPC) | |
| Summary Chemical<br>Composition | | The chemical composition slightly differs between the two devices to meet customer needs (improved moisture tolerance).<br>The subject device formulation has been thoroughly assessed for biocompatibility and the result of the Biocompatibility Assessment of Cervitec F is<br>substantially equivalent to the results for the predicate device. See attached Biocompatibility Assessment. | | | |
| Finished Device<br>Specification | Applicable standard: ISO<br>17730:2014- Dentistry –<br>Fluoride varnishes | No information available | No information available | Applicable standard: ISO<br>17730:2014- Dentistry -<br>Fluoride varnishes | |
| Sterilization | Not applicable. No sterilization<br>recommendation. | Not applicable. No sterilization<br>recommendation. | Non-sterile | Not applicable. No sterilization<br>recommendation. | |
| Single use | Consumable material | Single use only | No information available | Consumable material | |
| Summary of Finished<br>Device Specification | According to EN ISO 17730:2014 "Dentistry – fluoride varnishes" apart from the total fluoride content (the total fluoride content shall not deviate<br>by more than 20% from the stated amount on the package), no other properties appear as being relevant for having the device functioning or<br>performing as intended.<br><br>Specific physical properties have been assessed and verified according to product standard EN ISO 17730:2014 - Dentistry- fluoride varnishes".<br>The acceptance criteria of EN ISO 17730:2014 (the total fluoride content shall not deviate by more than 20% from the stated amount on the<br>package) was fulfilled. | | | | |
| Summary of<br>Performance<br>Specification | 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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