(256 days)
No
The device description and performance studies focus on the chemical and physical properties of a dental varnish, with no mention of AI or ML.
Yes
The device is a dental varnish intended for the treatment of dentinal hypersensitivity, which is a therapeutic purpose.
No
Explanation: The "Intended Use / Indications for Use" and "Device Description" sections explicitly state the device is for "treatment of dentinal hypersensitivity," which indicates a therapeutic purpose rather than a diagnostic one. There is no mention of identifying, detecting, or measuring a condition.
No
The device description clearly states it is a "dental varnish" and comes in "Tube" or "Single Dose" delivery forms, indicating a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of dentinal hypersensitivity. IVDs are used for the diagnosis or monitoring of diseases or conditions.
- Device Description: The device is a dental varnish applied to the teeth. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body (like blood, urine, tissue).
- Mechanism of Action: The description implies a therapeutic effect (treating hypersensitivity), not a diagnostic one.
- Performance Studies: The performance studies focus on compliance with standards for fluoride varnishes and biocompatibility, not on diagnostic accuracy metrics like sensitivity, specificity, etc.
Therefore, Cervitec®F is a therapeutic dental device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For treatment of dentinal hypersensitivity secondary to exposed dentin and root cervical surfaces.
Product codes (comma separated list FDA assigned to the subject device)
LBH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dentin and root cervical surfaces
Indicated Patient Age Range
all age groups
Intended User / Care Setting
dentist, dental prophylaxis assistants or professionally instructed personnel.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Fluor Protector S (K131487)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Cervitec Plus (K072338), Biotene Mouthspray (K103745)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
1
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 Ivoclar
Vivadent, Inc.
175 Pineview Drive Amherst,
New York 14228 716-691-
2045
lori.aleshin@ivoclarvivadent.com | |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Company: | Ivoclar Vivadent, AG
Bendererstrasse 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 Consumer
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
Device:
Fluor Protector S
(K131487) | Reference Device:
Cervitec Plus (K072338) | Reference Device: Biotene
Mouthspray (K103745) | Subject Device: Cervitec® F
(K191453) | |
|----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Manufacturer | Ivoclar Vivadent AG | Ivoclar Vivadent AG | Glaxosmithkline Consumer
Healthcare | Ivoclar Vivadent AG | |
| Indications for Use | Fluor Protector S is a
protective fluoride varnish for
tooth desensitization.
- Treatment of dentinal
hypersensitivity - Treatment of exposed
cervicals - Treatment of sensitivity
after tooth whitening | Cervitec Plus is a dental varnish
material that is used for the
protection of exposed root surfaces
and treatment of hypersensitive
cervicals | Relieves the symptoms of dry mouth;
refreshes, moisturizes, sooths oral
irritation, and lubricates oral dryness. | For treatment of dentinal
hypersensitivity secondary to exposed
dentin and root cervical surfaces. | |
| Precaution
Measures/
Contraindications/
Processing
restrictions/ Side
effects | Contraindication
If patients are known to be
allergic to any of the
ingredients of Fluor Protector
S, the material should not be
used.
Application
Fluor Protector S is applied by
dentists and dental
professionals. Fluor Protector S
is suitable for treating patients
of all ages.
Side effects
A slight temporary burning
sensation may occur if the
product comes in contact with
the mucous membrane. | Contraindication
If patients are known to be allergic to
any of the ingredients in Cervitec Plus,
the material should not be applied.
Application
Cervitec Plus can be used for patients
of all age groups and is professionally
applied by dentists, dental hygienists
or dental prophylaxis assistants.
Generally, Cervitec Plus is applied
every three months. If intensive
treatment is required, however, the
varnish may also be applied more
frequently. One Free Stand Single
Dose Cervitec Plus is enough for the
treatment of one set of teeth. One
tube is enough for about 20-30 sets
of teeth. | No information available | Contraindication
If users are known to be allergic to any
of the ingredients in Cervitec F, the
material should not be applied.
Application
Cervitec F is applied by the dentist,
dental hygienists, dental prophylaxis
assistants or professionally instructed
personnel. Cervitec F is suitable for all
age groups.
Side effects
Contact with the mucous membrane
may result in short term, reversible
irritation.
Chlorhexidine may cause reversible
discoloration of thetooth structure and
restorations. In rare, isolated cases,
chlorhexidine may cause allergic
reactions. | |
| | | | | | |
| | | Warning
In rare, isolated cases, chlorhexidine may cause allergic reactions.
Side effects
In 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 of
Indications,
Precaution
Measures/
Contraindications/
Processing
restrictions/
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
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
of liquid 7g Single dose
0.26g | Single dose Multi
dose | 1.5 oz non-pressurized pump action spray
bottle fitted with cap | Tube of liquid 4g Tube
of liquid 7g Single dose
0.26g | |
| Summary of
Delivery
forms/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 of
Storage Conditions | | The shelf life and the storage conditions are the same as for the predicate device Fluor Protector S. | | | |
| Principles of
Operation | Step-by-step: - Clean the tooth surfaces.
- Create a dry working field
with cotton rolls, cotton wool
wads and a saliva ejector or
air syringe if necessary. - a) Single dose units: Peel
the foil top from the single
dose unit; apply the varnish
directly from the single dose
unit. - b) Dispensing tube:
Place the required amount
in a dappen dish or similar
vessel and close the tube. - Apply a thin layer with the
help of a Vivabrush G. - Let the varnish dry for one
minute; thereafter, remove
the cotton rolls. - After the treatment, ask
the patient to spit out the
contents of the mouth
without rinsing.
Tips for patients: patients
should refrain from eating
and drinking for one hour
after the treatment with
Fluor Protector S. | Step-by-step:
- Clean tooth surfaces
thoroughly. - Dry with cotton rolls and air
syringe. - a) Single Dose:
Remove the foil from the Single
Dose and apply the varnish
directly from the Single Dose.
b) Tube:
Press out 3 drops into, for
example, a dappen dish and
reseal the tube.
Hold the tube in a vertical position
with the cap facing upwards for
opening and closing. For pressing
out the contents, hold the opening
vertically down. - Apply a thin coat of varnish by
means of a Vivadent applicator or
suitable brush (diagram); in
proximal areas, Cervitec Plus is
applied with dental floss. - Let the varnish dry. The
varnish can be dispersed with air. - Remove cotton rolls after 30
seconds. - Ask patients not to rinse their
mouth. | Method of Use: Ready to use spray
Applications per Day: As needed | Step-by-step:
- Clean the tooth surfaces.
- Isolate the application area with
cotton rolls and cotton swabs. - The use of a saliva ejector or air
syringe is optional. - a) Single Dose unit: Remove the
foil from the Single Dose and apply
the varnish directly from the Single
Dose. - b) Dosing tube: Dispense the
required amount into e.g. a dappen
dish and close the tube again. - Apply the varnish in a thin layer
using e.g. Vivabrush G. - Allow the varnish to dry for 1
minute and then remove the cotton
rolls. - No rinsing after application, only
spitting.
Eating and drinking should be
avoided for 1 hour after application
of Cervitec F.
Vivabrush G is a class I medical
device - therefore no 510(k) required | |
| Summary Principles
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
Chlorhexidine diacetate (CHX) | Cetylpyridinium chloride (CPC) | VA/Crotonates Copolymer,
Chlorhexidine diacetate (CHX) and
Cetylpyridinium chloride (CPC) | |
| Summary Chemical
Composition | | 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 is
substantially equivalent to the results for the predicate device. See attached Biocompatibility Assessment. | | | |
| Finished Device
Specification | Applicable standard: ISO
17730:2014- Dentistry –
Fluoride varnishes | No information available | No information available | Applicable standard: ISO
17730:2014- Dentistry -
Fluoride varnishes | |
| Sterilization | Not applicable. No sterilization
recommendation. | Not applicable. No sterilization
recommendation. | Non-sterile | Not applicable. No sterilization
recommendation. | |
| Single use | Consumable material | Single use only | No information available | Consumable material | |
| Summary of Finished
Device Specification | According to EN ISO 17730:2014 "Dentistry – fluoride varnishes" apart from the total fluoride 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.
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 the
package) was fulfilled. | | | | |
| Summary of
Performance
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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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) .