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Pulpdent Snoop

FDA 510(k)

Class II (US FDA 510(k))

510(k) K964430

by Pulpdent Corporation

Identifiers

510(k) Number
K964430 FDA 510(k)
FDA Product Code
LFC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.1740 FDA 510(k)
Regulation Number
872.1740 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Snoop Caries Detecting Dye is a diagnostic tool classified as a caries detection device, designed to differentiate between infected and affected dentin in dental preparations. It visually identifies carious (decayed) tissue within 10 seconds, aiding in the preservation of healthy dentin during cavity preparations.

This device is supplied as a single-use, non-sterile solution in a 12 mL bottle and is intended for use in dental settings. It is regulated under FDA 510(k) clearance (K964430) and falls under Class II medical devices, adhering to regulatory standards for dental diagnostics. No MRI safety or sterility requirements are specified.

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: Snoop Caries Detecting Dye - PULPDENT, Snoop™ Caries Detecting Dye Transitioning to New Bottle - PULPDENT, Snoop | Pulpdent Corporation | DPS - Dental Product Shopper

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) K964430 24 fields · synced Sep 18, 2026