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Found 2 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM

Manufacturer

PAXMED INTERNATIONAL

Date Cleared

2001-09-20

(153 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

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

QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM

Manufacturer

QUANTUM BIOENGINEERING, LTD.

Date Cleared

2001-09-20

(423 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K112279,K130787

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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