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FDA 510(k)

ENDO-EXPRESS (R) HANDPIECE

K-Number: K111541 · 2012-03-16

ApplicantEssential Dental Systems, Inc.
Decision Date2012-03-16
Product CodeEGS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENDO-EXPRESS (R) HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Essential Dental Systems, Inc.. It received FDA 510(k) clearance on 2012-03-16 under 510(k) number K111541. The device is classified under product code EGS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDO-EXPRESS (R) HANDPIECE?

ENDO-EXPRESS (R) HANDPIECE is a medical device that received FDA 510(k) clearance on 2012-03-16. The listed applicant is Essential Dental Systems, Inc.. The 510(k) number is K111541.

When did ENDO-EXPRESS (R) HANDPIECE receive FDA 510(k) clearance?

ENDO-EXPRESS (R) HANDPIECE received FDA 510(k) clearance on 2012-03-16, under 510(k) number K111541.

Who is the listed applicant for ENDO-EXPRESS (R) HANDPIECE?

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

What is the FDA product code for ENDO-EXPRESS (R) HANDPIECE?

The FDA product code for ENDO-EXPRESS (R) HANDPIECE is EGS.

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Other records listing Essential Dental Systems, Inc. as applicant

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K223340EDS Calculus Softener TURBO CRK152691EDS Universal CementK101504TI-CORE FLOWK072555EDTA PLUSK070401ENDO-CHXK063856EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM

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Related Devices (Code: EGS)

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.

K251869Disposable Prophy Angle (3399-60, 3399-090, 3399-105)Premium Plus (Dongguan) LimitedK240950Disposable Prophy AnglePacific Care LimitedK240183Star E900 Handpiece SeriesDentalez, Inc., Stardental DivisionK230106General Cutting StraightNakanishi, Inc.K222518FX ContraNakanishi, Inc.K220874Smooth Drive contra angle and straight handpiecesLares Research

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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