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FDA 510(k)

LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE

K-Number: K050612 · 2005-05-04

ApplicantLightspeed Technology, Inc.
Decision Date2005-05-04
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Lightspeed Technology, Inc.. It received FDA 510(k) clearance on 2005-05-04 under 510(k) number K050612. 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 LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE?

LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE is a medical device that received FDA 510(k) clearance on 2005-05-04. The listed applicant is Lightspeed Technology, Inc.. The 510(k) number is K050612.

When did LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE receive FDA 510(k) clearance?

LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE received FDA 510(k) clearance on 2005-05-04, under 510(k) number K050612.

Who is the listed applicant for LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE?

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

What is the FDA product code for LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE?

The FDA product code for LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE is EKX.

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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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