VLC Dycal II
510(k) K922721
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK922721 | Date23 Jul 1992 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- EJK
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3250
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The VLC Dycal II is a Cavity Liner, Calcium Hydroxide (product code EJK), classified under FDA’s Class II special controls. As a visible-light-cured, one-component material, it provides a protective base or liner beneath dental adhesives, varnishes, restorative materials, and other base applications. Its primary function is to promote pulp protection in direct and indirect pulp capping procedures while ensuring biocompatibility with subsequent restorative treatments.
Supplied as a single-use, sterile material, VLC Dycal II is intended for use in dental settings where pulp preservation is required. The product is packaged for individual applications and adheres to FDA’s 510(k) clearance (K922721) under regulatory number 872.3250, with no MRI restrictions noted. Storage conditions and shelf life are not specified in the regulatory data, but standard dental material handling practices apply. Authorized for use in the United States, it is distributed under Dentsply International’s commercial designation.
Other devices from Dentsply Intl.
Questions
AI-generated answers, 1 Oct 2026
What is the VLC Dycal II used for in dental procedures?
The VLC Dycal II is a visible-light-cured, one-component calcium hydroxide liner designed to provide protective base coverage beneath dental adhesives, varnishes, and restorative materials. Its primary purpose is to promote pulp protection during direct and indirect pulp capping procedures, ensuring biocompatibility with subsequent restorative treatments while safeguarding dental pulp health.
How is the VLC Dycal II supplied and what does this mean for clinical use?
The VLC Dycal II is supplied as a single-use, sterile material, meaning each package is intended for one application only. This ensures sterility and reduces the risk of cross-contamination between patients, which is critical in dental settings where infection control is paramount. Clinicians should open the package immediately before use and adhere to standard dental material handling practices.
Is the VLC Dycal II reusable or intended for single applications?
The VLC Dycal II is explicitly designed for single-use applications. This is a standard practice for materials that come into direct contact with biological tissues to prevent infection and ensure patient safety. Reusing dental materials like this can compromise sterility and increase the risk of complications, so it is not recommended.
Are there any specific storage instructions or shelf-life considerations for the VLC Dycal II?
The regulatory data does not specify exact storage conditions or shelf life for the VLC Dycal II. However, as with most dental materials, it should be stored in a clean, dry environment away from direct sunlight and extreme temperatures. Following standard dental material handling practices—such as keeping it in its original packaging until use—will help maintain its integrity and effectiveness.
Can the VLC Dycal II be used with MRI procedures, and are there any restrictions?
The regulatory data for the VLC Dycal II does not mention any MRI restrictions. This means it is generally safe to use in patients who require MRI scans, as there is no indication that the material contains metallic or ferromagnetic components that could interfere with imaging. However, clinicians should always verify compatibility with the specific MRI equipment and protocols being used.