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Found 4 results

510(k) Data Aggregation

K Number

K965216

Device Name

ARGI-SATIN OR OPTI0-STAR

Manufacturer

ARGEN PRECIOUS METALS, INC.

Date Cleared

1997-02-27

(59 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

K961352

Device Name

285 SL

Manufacturer

ARGEN PRECIOUS METALS, INC.

Date Cleared

1996-05-20

(42 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

K961211

Device Name

ARGELITE 52+

Manufacturer

ARGEN PRECIOUS METALS, INC.

Date Cleared

1996-04-25

(28 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

K961285

Device Name

ARGEDENT 40(GOLD-PALLADIUM-SILVER ALLOY FOR PORCELAIN APPLICATION)

Manufacturer

ARGEN PRECIOUS METALS, INC.

Date Cleared

1996-04-18

(15 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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