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Pulpdent Cavity Cleanser, Pulpdent Cavity Cleanser Plus

FDA 510(k)

Class II (US FDA 510(k))

510(k) K974202

by Pulpdent Corporation

Identifiers

510(k) Number
K974202 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 Cleanser and Pulpdent Cavity Cleanser Plus are dental cavity varnishes designed to cleanse and moisten prepared tooth cavities. These products are applied to dentin tubules to prepare the surface for adhesive bonding or sealing, ensuring optimal adhesion of restorative materials such as veneers, inlays, crowns, onlays, amalgams, and composite resins.

These products are supplied as single-use dental varnishes and are intended for use in clinical dental settings. They are classified under FDA product code LBH as Class II devices under special controls. The Pulpdent Cavity Cleanser and Pulpdent Cavity Cleanser Plus received FDA 510(k) clearance in 1998, confirming their substantial equivalence to a predicate device. Storage and handling follow standard dental practice guidelines for liquid dental materials.

Frequently asked questions

What is the primary purpose of the Pulpdent Cavity Cleanser and Cavity Cleanser Plus in dental procedures?

The Pulpdent Cavity Cleanser and Cavity Cleanser Plus are dental cavity varnishes designed to cleanse and moisten prepared tooth cavities. Their main function is to prepare the dentin surface for adhesive bonding or sealing, ensuring optimal adhesion of restorative materials such as veneers, inlays, crowns, onlays, amalgams, and composite resins.

Are these products single-use or reusable, and how should they be stored?

Both the Pulpdent Cavity Cleanser and Cavity Cleanser Plus are supplied as single-use dental varnishes. Storage and handling follow standard dental practice guidelines for liquid dental materials, which typically involve keeping them in a clean, dry environment away from direct sunlight and extreme temperatures.

What regulatory pathway was followed for FDA clearance of these products, and when was it granted?

The Pulpdent Cavity Cleanser and Cavity Cleanser Plus received FDA 510(k) clearance in 1998 through a traditional review process. The clearance confirmed their substantial equivalence to a predicate device, and they are classified under FDA product code LBH as Class II devices under special controls.

Are there any differences between the Pulpdent Cavity Cleanser and Cavity Cleanser Plus, or are they essentially the same?

While both products are cavity varnishes with the same primary purpose of cleansing and moistening prepared tooth cavities, the specific formulation differences are not detailed in the provided data. They are both intended for adhesive bonding or sealing of restorative materials, but the

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 Cleanser, Pulpdent Cavity Cleanser Plus (K974202) — Fda ..., K974202 - PULPDENT CAVITY CLEANSER | FDA 510(k) | Pulpdent Corp., Pulpdent Cavity Cleanser, Pulpdent Cavity Cleanser Plus 510 (k) FDA ..., Pulpdent Cavity Cleanser, Pulpdent Cavity Cleanser Plus (K974202) — Fda ...

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) K974202 24 fields · synced Sep 18, 2026