Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Dental Handpiece, Model CA160, CA160L, and CA500L

K-Number: K220577 · 2022-07-29

ApplicantMicro-Nx Co., Ltd.
Decision Date2022-07-29
Product CodeEGS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Handpiece, Model CA160, CA160L, and CA500L is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Nx Co., Ltd.. It received FDA 510(k) clearance on 2022-07-29 under 510(k) number K220577. 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 Dental Handpiece, Model CA160, CA160L, and CA500L?

Dental Handpiece, Model CA160, CA160L, and CA500L is a medical device that received FDA 510(k) clearance on 2022-07-29. The listed applicant is Micro-Nx Co., Ltd.. The 510(k) number is K220577.

When did Dental Handpiece, Model CA160, CA160L, and CA500L receive FDA 510(k) clearance?

Dental Handpiece, Model CA160, CA160L, and CA500L received FDA 510(k) clearance on 2022-07-29, under 510(k) number K220577.

Who is the listed applicant for Dental Handpiece, Model CA160, CA160L, and CA500L?

The FDA 510(k) record lists Micro-Nx Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Handpiece, Model CA160, CA160L, and CA500L?

The FDA product code for Dental Handpiece, Model CA160, CA160L, and CA500L is EGS.

Other records listing Micro-Nx Co., Ltd. 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.

K231562ELEC ENGINE (Model: ISE-170L)K232810Dental Handpiece, Wireless Endodontic Handpiece, endoitK201191ELEC-LEDK201192Impla-NX (Model: ISE-270M)K192809Dental HandpieceK161500MEG-TORQ

View all 7 devices →

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.

↑