Fluor Protector S Varnish
510(k) K131487
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK131487 | Date8 Oct 2014 | 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- Withdrawn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
- Fluor Protector S
- 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 Fluor Protector S Varnish is a dental cavity varnish designed to deliver fluoride protection for dental enamel. It is classified as a cavity varnish and contains a homogeneously dissolved fluoride source to ensure immediate fluoride availability, helping to prevent dental caries and enamel erosion.
This varnish is supplied as a low-viscosity liquid for direct application to dental enamel. It is intended for single-use in dental settings and has received FDA 510(k) clearance under the Traditional pathway as Substantially Equivalent. The product is categorized under Class II medical devices (regulation number 872.3260) and is regulated for dental use.
From the manufacturer
The protective fluoride varnish provides superior protection against dental caries and erosion [1-4]. The innovative varnish system of Fluor Protector S featuring a homogeneously dissolved fluoride source ensures immediate availability of the fluoride [5]. Dental enamel is directly and effectively supplied with fluoride [5].
The innovative varnish system of Fluor Protector S by Ivoclar features a homogeneously dissolved fluoride source ensures immediate availability of the fluoride.
Other devices from Ivoclar Vivadent AG
Questions
AI-generated answers, 18 Sep 2026
What is the Fluor Protector S Varnish primarily used for in dental practice?
The Fluor Protector S Varnish is designed to deliver fluoride protection for dental enamel, helping to prevent dental caries (cavities) and enamel erosion. It is specifically formulated as a cavity varnish with a homogeneously dissolved fluoride source to ensure immediate fluoride availability upon application.
How is the Fluor Protector S Varnish supplied, and is it intended for single-use?
The Fluor Protector S Varnish is supplied as a low-viscosity liquid, making it easy to apply directly to dental enamel. According to the data, it is intended for single-use in dental settings, meaning each application should use a fresh unit to maintain sterility and effectiveness.
Is the Fluor Protector S Varnish sterile, and if so, how should it be stored?
While the provided data does not explicitly state whether the varnish is sterile *as packaged*, it is classified as a single-use dental product, implying it should be handled in a sterile manner during application. Storage instructions are not detailed, but generally, dental varnishes should be kept in a cool, dry place, away from direct sunlight, and protected from contamination until use.
What regulatory pathway was followed for FDA clearance of the Fluor Protector S Varnish?
The Fluor Protector S Varnish received FDA clearance under the Traditional 510(k) pathway, specifically determined to be Substantially Equivalent (SESE) to a predicate device. This means the manufacturer demonstrated that it is as safe and effective as a legally marketed device already on the market. The clearance was granted on October 8, 2014, under product code LBH and regulation number 872.3260.