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Found 3 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

LUTE-IT II VENEER CEMENT, MODEL NO6

Manufacturer

PENTRON CLINICAL TECHNOLOGIES

Date Cleared

2008-08-29

(58 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Validate with FDA (Live)

Device Name

Manufacturer

FIRST SCIENTIFIC LIMITED

Date Cleared

2001-07-10

(54 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Validate with FDA (Live)

Device Name

LUTE VLC; CORE VLC

Manufacturer

FIRST SCIENTIFIC LIMITED

Date Cleared

2001-06-22

(53 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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Ask a specific question about this device

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