Pulpdent Cavity Preparation IV
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K013411 FDA 510(k)
- FDA Product Code
- LBH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3260 FDA 510(k)
- Regulation Number
- 872.3260 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pulpdent Cavity Preparation IV is a Cavity Varnish, a dental adhesive agent designed to prepare tooth surfaces during restorative procedures. It is an aqueous solution applied to clean and condition the cavity prior to placement of restorative materials such as veneers, inlays, crowns, onlays, amalgam, or composite resins. Its primary function is to enhance adhesion and protect the dentin during preparation.
This device is supplied as a single-use solution and is intended for use in clinical dental settings. It is classified as a Class II medical device under FDA regulation 872.3260 and holds a FDA 510(k) clearance with the product code LBH. The solution is non-sterile and must be prepared or handled in accordance with dental practice standards. No additional regulatory markings beyond the 510(k) clearance are specified.
Frequently asked questions
What is the primary purpose of the Pulpdent Cavity Preparation IV in dental procedures?
The Pulpdent Cavity Preparation IV is a cavity varnish designed to prepare tooth surfaces during restorative procedures. Its main functions are to enhance adhesion of restorative materials—such as veneers, inlays, crowns, onlays, amalgam, or composite resins—and to protect the dentin during preparation. By conditioning the cavity, it helps improve the bond strength and longevity of the final restoration.
Is the Pulpdent Cavity Preparation IV sterile, and how should it be handled in a clinical setting?
The Pulpdent Cavity Preparation IV is non-sterile, so it must be prepared or handled in accordance with standard dental practice protocols to ensure sterility at the point of use. Clinicians should follow established infection control measures, such as using sterile applicators or syringes, to apply the solution to the cavity. Always refer to manufacturer guidelines for proper preparation and usage.
How is the Pulpdent Cavity Preparation IV supplied, and is it intended for single-use?
The Pulpdent Cavity Preparation IV is supplied as a single-use solution, meaning each bottle or container is designed for one application. This ensures consistency and prevents cross-contamination. After use, the remaining solution should be discarded, and a new single-use unit should be opened for subsequent procedures.
What types of restorative materials is the Pulpdent Cavity Preparation IV compatible with?
The Pulpdent Cavity Preparation IV is specifically designed to prepare tooth surfaces for a variety of restorative materials, including veneers, inlays, crowns, onlays, amalgam, and composite resins. Its adhesive properties help improve the bond between the tooth structure and the restorative material, enhancing the durability of the final restoration.
What regulatory pathway was followed for the FDA clearance of the Pulpdent Cavity Preparation IV?
The Pulpdent Cavity Preparation IV received FDA 510(k) clearance under the traditional review pathway, classified as a Class II medical device under regulation 872.3260. The submission was reviewed by the Dental (DE) Advisory Committee, and the device was determined to be substantially equivalent to a predicate product. The clearance was granted on December 12, 2001, with the product code LBH.
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: PULPDENT CAVITY PREPARATION IV (K013411) — FDA 510 (k) | Innolitics, PULPDENT CAVITY PREPARATION IV 510 (k) K013411 - FDA.report, PULPDENT ® Corporation - Advancing Dentistry Together
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K013411 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K013411 24 fields · synced Sep 20, 2026