K Number
K964430Device Name
PULPDENT SNOOPManufacturer
Date Cleared
1997-01-17
(73 days)
Product Code
Regulation Number
872.1740Type
TraditionalPanel
DEReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 872.1740 Caries detection device.
(a)
Identification. The caries detection device is a device intended to show the existence of decay in a patient's tooth by use of electrical current.(b)
Classification. Class II.