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FDA 510(k)

TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE

K-Number: K112665 · 2012-05-04

ApplicantJ. Morita USA, Inc.
Decision Date2012-05-04
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE 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 2012-05-04 under 510(k) number K112665. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE?

TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE is a medical device that received FDA 510(k) clearance on 2012-05-04. The listed applicant is J. Morita USA, Inc.. The 510(k) number is K112665.

When did TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE receive FDA 510(k) clearance?

TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE received FDA 510(k) clearance on 2012-05-04, under 510(k) number K112665.

Who is the listed applicant for TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE?

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 TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE?

The FDA product code for TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE is EKX.

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Other records listing J. Morita USA, Inc. as applicant

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Related Devices (Code: EKX)

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.

K261987Reusable SmartPegOsstell ABK252223Alpha Endo Handpiece (Alpha Endo)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K251597InnerView SystemPerimetrics, Inc.K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L.K242514Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)Shenzhen Rogin Medical Co., Ltd.K241065ChecQ (AC100)Dentis Co., Ltd.

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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