Identifiers
- 510(k) Number
- K113711 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 II is a calcium hydroxide cavity liner, classified as a dental liner under FDA classification II. It is designed to provide a protective barrier between dental restorative materials and the pulp of a tooth, promoting healing and reducing sensitivity by creating a biocompatible environment. This liner is formulated to enhance moisture tolerance, supporting its use in adhesive and composite restorative techniques.
Supplied as a single-use, light-curable syringe kit, the Lime-Lite II is intended for dental professionals in clinical settings. It requires no sterilization as it is intended for one-time use per application. The device is not MRI-safe, and its use is governed by FDA 510(k) clearance (K113711) under regulation number 872.3250. Storage should follow manufacturer guidelines to maintain product integrity, and it is regulated as a Class II medical device under the Dental advisory committee classification.
Frequently asked questions
What is the primary purpose of the Lime-Lite II in dental procedures?
The Lime-Lite II is designed as a calcium hydroxide cavity liner to act as a protective barrier between dental restorative materials and the tooth pulp. Its purpose is to promote pulp healing, reduce sensitivity, and create a biocompatible environment, particularly when used with adhesive or composite restorative techniques.
How is the Lime-Lite II supplied, and is it reusable?
The Lime-Lite II is supplied as a single-use, light-curable syringe kit, meaning each kit is intended for one application only. Since it is not meant to be reused, there is no need for sterilization between uses.
Are there any special storage requirements for the Lime-Lite II?
The Lime-Lite II should be stored according to the manufacturer’s guidelines to maintain its integrity. While specific storage conditions aren’t detailed in the data, adhering to the provided instructions ensures the product remains effective for its intended use.
Does the Lime-Lite II have any compatibility concerns with MRI machines?
The Lime-Lite II is explicitly noted as not MRI-safe, so it should not be used in patients who require MRI imaging. Clinicians should avoid placing the device in areas where MRI scans may be needed.
What regulatory pathway does the Lime-Lite II follow, and how is it classified?
The Lime-Lite II is classified as a Class II medical device under the FDA’s Dental advisory committee (DE) and was cleared through a Traditional 510(k) pathway (K113711). It falls under regulation number 872.3250 and is intended for use as a dental liner, specifically a calcium hydroxide cavity liner.
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 - PULPDENT, Product Catalog: ACTIVA, Lime-Lite Enhanced and More - PULPDENT, Lime-lite Ii 510 (k) FDA Premarket Notification K113711 PULPDENT ..., Lime-Lite Enhanced LLE Cavity Liner - Henry Schein Dental, Lime-Lite Enhanced Light Cure Cavity Liner - Pulpdent
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K113711 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
Sources (1)
- FDA 510(k) K113711 24 fields · synced Sep 20, 2026