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Limelight

FDA 510(k)

Class II (US FDA 510(k))

510(k) K953079

by Pulpdent Corporation

Identifiers

510(k) Number
K953079 FDA 510(k)
FDA Product Code
EJK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3250 FDA 510(k)
Regulation Number
872.3250 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Lime-Lite Enhanced Cavity Liner is a dental material classified as a Cavity Liner, Calcium Hydroxide, designed to provide a protective barrier between dental pulp and restorative materials. It contains calcium hydroxide, which promotes dentin formation and supports pulp healing in prepared cavities.

This product is supplied as a syringe kit for single-use application in dental settings. It is intended for use in restorative procedures and is regulated under FDA 510(k) clearance (K953079) as a Class II device. The liner is non-sterile and must be sterilized by the user prior to application, adhering to standard dental sterilization protocols.

Frequently asked questions

What is the Lime-Lite Enhanced Cavity Liner primarily used for in dental procedures?

The Lime-Lite Enhanced Cavity Liner is designed to act as a protective barrier between dental pulp and restorative materials during cavity preparations. Its key function is to promote dentin formation and support pulp healing, making it ideal for use in restorative procedures where pulp protection is necessary.

How is the Lime-Lite Enhanced Cavity Liner supplied, and is it intended for single-use?

The Lime-Lite Enhanced Cavity Liner is supplied as a syringe kit, specifically formulated for single-use application in dental settings. This ensures sterility and safety for each patient treatment, as it is not intended for reuse.

Is the Lime-Lite Enhanced Cavity Liner sterile, and if not, how should it be prepared for use?

The Lime-Lite Enhanced Cavity Liner is not sterile as supplied. It must be sterilized by the user prior to application, following standard dental sterilization protocols to ensure safety and efficacy before use in procedures.

What regulatory pathway was followed for FDA clearance of the Lime-Lite Enhanced Cavity Liner?

The Lime-Lite Enhanced Cavity Liner was cleared through the FDA’s 510(k) process under the traditional review pathway, with a decision code of SESE (Substantially Equivalent in Safety and Effectiveness). It was classified as a Class II device and received clearance under the product code EJK, with a specific registration number (e.g., K953079).

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Lime-Lite Enhanced LLE Cavity Liner - Henry Schein Dental, PDF PULPDENT® Lime-Lite™ Enhan - content.pattersondental.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pulpdent Corporation
FDA Applicant
Pulpdent Corp.

Sources (1)

  • FDA 510(k) K953079 24 fields · synced Sep 18, 2026