Cervitec F Varnish
510(k) K191453
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK191453 | Date11 Feb 2020 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Cervitec F
- 510(k) Number
- FDA product code
- LBH
- FDA applicant
- Ivoclar Vivadent, AG
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3260
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Cervitec F Varnish is a dental cavity varnish designed to provide antimicrobial and protective properties. It combines chlorhexidine, thymol, and fluoride to help reduce bacterial colonization and strengthen tooth enamel, contributing to the prevention and treatment of gingivitis and periodontitis.
This product is supplied as a single-use application in a tube format, intended for use in dental clinical settings. It is classified as a Class II medical device under FDA regulations and has received 510K clearance. The varnish is non-sterile and must be stored according to manufacturer guidelines, ensuring protection from moisture and extreme temperatures. No MRI safety information is specified.
From the manufacturer
Cervitec Plus, Cervitec F, Cervitec Gel and Cervitec Liquid are chlorhexidine products used for prevention and treatment of gingivitis and periodontitis.
Cervitec® F Fluoride, Chlorhexidine, and CPC Varnish Cervitec® Plus is an innovative protective varnish from Ivoclar Vivadent containing the combination of 1% chlorhexidine and 1% thymol for clinically proven, long lasting, advanced protection.
Other devices from Ivoclar Vivadent AG
Questions
AI-generated answers, 18 Sep 2026
What are the key active ingredients in Cervitec F Varnish and how do they benefit dental health?
Cervitec F Varnish contains chlorhexidine, thymol, and fluoride. Chlorhexidine provides antimicrobial properties to reduce bacterial colonization, thymol offers additional antibacterial effects, and fluoride strengthens tooth enamel to help prevent cavities and support overall oral health. Together, these ingredients contribute to the prevention and treatment of gingivitis and periodontitis.
Is Cervitec F Varnish intended for single-use or repeated applications, and how is it packaged?
Cervitec F Varnish is supplied as a single-use application in a tube format, specifically designed for one-time use in dental clinical settings. This ensures sterility and usability per application, reducing the risk of cross-contamination.
How should Cervitec F Varnish be stored, and why is this important?
Cervitec F Varnish must be stored according to manufacturer guidelines, protecting it from moisture and extreme temperatures. This is critical because moisture can degrade the varnish’s properties, while extreme temperatures may alter its consistency or effectiveness, ensuring optimal performance when used.
What regulatory pathway was followed for Cervitec F Varnish, and what does this mean for its use?
Cervitec F Varnish followed the FDA’s 510(k) traditional clearance pathway and was determined to be *substantially equivalent* to a predicate device. This means it has been reviewed and cleared as a Class II medical device for dental use, adhering to FDA safety and effectiveness standards. The clearance does not imply its specific clinical indications but confirms its compliance with regulatory requirements.
Is Cervitec F Varnish sterile, and if not, what precautions should be taken during use?
Cervitec F Varnish is explicitly labeled as *non-sterile*. Since it is intended for direct application in dental procedures, clinicians should follow standard aseptic techniques, such as using sterile applicators or gloves, to minimize infection risk during use.