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FDA 510(k)

AEU-26L ELCTRONIC ENDODONTIC SYSTEM

K-Number: K111078 · 2011-06-14

ApplicantAseptico, Inc.
Decision Date2011-06-14
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AEU-26L ELCTRONIC ENDODONTIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aseptico, Inc.. It received FDA 510(k) clearance on 2011-06-14 under 510(k) number K111078. 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 AEU-26L ELCTRONIC ENDODONTIC SYSTEM?

AEU-26L ELCTRONIC ENDODONTIC SYSTEM is a medical device that received FDA 510(k) clearance on 2011-06-14. The listed applicant is Aseptico, Inc.. The 510(k) number is K111078.

When did AEU-26L ELCTRONIC ENDODONTIC SYSTEM receive FDA 510(k) clearance?

AEU-26L ELCTRONIC ENDODONTIC SYSTEM received FDA 510(k) clearance on 2011-06-14, under 510(k) number K111078.

Who is the listed applicant for AEU-26L ELCTRONIC ENDODONTIC SYSTEM?

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

What is the FDA product code for AEU-26L ELCTRONIC ENDODONTIC SYSTEM?

The FDA product code for AEU-26L ELCTRONIC ENDODONTIC SYSTEM 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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