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Found 4 results

510(k) Data Aggregation

K Number

Device Name

Manufacturer

MICRO MOTORS, INC.

Date Cleared

2000-02-03

(16 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

Device Name

DYNA TORQ TORQUE WRENCH, TORQUE WRENCH

Manufacturer

MICRO MOTORS, INC.

Date Cleared

1999-08-18

(125 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

The Dyna Torq Torque Wrench is intended for use in fastening dental implant abutments during the placement of dental implants.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental tool, the Dyna Torq® Torque Wrench. It does not contain information about studies, acceptance criteria, or device performance metrics as requested in the prompt. The letter merely states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on this document.

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K Number

Device Name

ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT

Manufacturer

MICRO MOTORS, INC.

Date Cleared

1997-03-31

(187 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

Device Name

STERILE WATER PUMP

Manufacturer

MICRO MOTORS, INC.

Date Cleared

1997-03-05

(62 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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