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FDA 510(k)

Lotus Prophy Angle

K-Number: K220346 · 2022-11-07

ApplicantAjk Engineering, Inc.
Decision Date2022-11-07
Product CodeEGS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Lotus Prophy Angle is the device name listed in this FDA 510(k) record. The listed applicant is Ajk Engineering, Inc.. It received FDA 510(k) clearance on 2022-11-07 under 510(k) number K220346. 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 Lotus Prophy Angle?

Lotus Prophy Angle is a medical device that received FDA 510(k) clearance on 2022-11-07. The listed applicant is Ajk Engineering, Inc.. The 510(k) number is K220346.

When did Lotus Prophy Angle receive FDA 510(k) clearance?

Lotus Prophy Angle received FDA 510(k) clearance on 2022-11-07, under 510(k) number K220346.

Who is the listed applicant for Lotus Prophy Angle?

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

What is the FDA product code for Lotus Prophy Angle?

The FDA product code for Lotus Prophy Angle is EGS.

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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