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K Number
K993846
Device Name
ULTRASEAL XT PLUS
Manufacturer
ULTRADENT PRODUCTS, INC.
Date Cleared
2000-02-16

(96 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

Use UltraSeal XT plus for prophylactic sealing of pits and fissures. It may also be used for microrestorative or "initial layer" of composite restorations.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a dental sealant product called "UltraSeal XT Plus." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Based on the content of the provided text, I cannot answer your request. The document discusses regulatory approval for a dental sealant and does not include the type of technical study details you are asking for.

§ 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.