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K Number
K050871
Device Name
RIVA PROTECT
Manufacturer
SOUTHERN DENTAL INDUSTRIES, INC.
Date Cleared
2005-06-10

(65 days)

Product Code
EBC
Regulation Number
872.3765
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Pit and fissure sealing. Root/tooth surface protection and hypersensitivity prevention. Temporary restorations in non load-bearing applications, temporary endodontic sealing.

Device Description

Not Found

AI/ML Overview

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) premarket notification letter from the FDA regarding the Riva Protect device, classifying it and permitting its marketing. It does not include details on performance testing or clinical studies.

§ 872.3765 Pit and fissure sealant and conditioner.

(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.