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FDA 510(k)

HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H)

K-Number: K061701 · 2006-08-25

ApplicantJ. Morita USA, Inc.
Decision Date2006-08-25
Product CodeEFA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) is the device name listed in this FDA 510(k) record. The listed applicant is J. Morita USA, Inc.. It received FDA 510(k) clearance on 2006-08-25 under 510(k) number K061701. The device is classified under product code EFA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H)?

HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) is a medical device that received FDA 510(k) clearance on 2006-08-25. The listed applicant is J. Morita USA, Inc.. The 510(k) number is K061701.

When did HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) receive FDA 510(k) clearance?

HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) received FDA 510(k) clearance on 2006-08-25, under 510(k) number K061701.

Who is the listed applicant for HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H)?

The FDA 510(k) record lists J. Morita USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H)?

The FDA product code for HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) is EFA.

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Related Devices (Code: EFA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192809Dental HandpieceMicro-Nx Co., Ltd.K163239SMARTmaticKaltenbach & Voigt GmbHK101172RDT3 HANDPIECE HEAD MODEL RDT3Redent Nova, Ltd.K093894ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLEAnthogyrK092446INTRA LUX HEAD 3 LDSYKaltenbach & Voigt GmbH & Co.K090055LOW & HIGH SPEED KITDpm USA Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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