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FDA 510(k)

Star E900 Handpiece Series

K-Number: K240183 · 2024-09-19

ApplicantDentalez, Inc., Stardental Division
Decision Date2024-09-19
Product CodeEGS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Star E900 Handpiece Series is the device name listed in this FDA 510(k) record. The listed applicant is Dentalez, Inc., Stardental Division. It received FDA 510(k) clearance on 2024-09-19 under 510(k) number K240183. 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 Star E900 Handpiece Series?

Star E900 Handpiece Series is a medical device that received FDA 510(k) clearance on 2024-09-19. The listed applicant is Dentalez, Inc., Stardental Division. The 510(k) number is K240183.

When did Star E900 Handpiece Series receive FDA 510(k) clearance?

Star E900 Handpiece Series received FDA 510(k) clearance on 2024-09-19, under 510(k) number K240183.

Who is the listed applicant for Star E900 Handpiece Series?

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

What is the FDA product code for Star E900 Handpiece Series?

The FDA product code for Star E900 Handpiece Series is EGS.

Other records listing Dentalez, Inc., Stardental Division as applicant

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.

K251701Star E900 Electric System

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 LimitedK230106General Cutting StraightNakanishi, Inc.K222518FX ContraNakanishi, Inc.K220874Smooth Drive contra angle and straight handpiecesLares ResearchK220346Lotus Prophy AngleAjk Engineering, Inc.

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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