FDA 510(k)

Titan 3 Low Speed Angle Attachments

K-Number: K162397 · 2017-01-19

Decision Date2017-01-19

Product CodeEGS

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Titan 3 Low Speed Angle Attachments is the device name listed in this FDA 510(k) record. The listed applicant is Dentalez, Inc.. It received FDA 510(k) clearance on 2017-01-19 under 510(k) number K162397. 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 Titan 3 Low Speed Angle Attachments?

Titan 3 Low Speed Angle Attachments is a medical device that received FDA 510(k) clearance on 2017-01-19. The listed applicant is Dentalez, Inc.. The 510(k) number is K162397.

When did Titan 3 Low Speed Angle Attachments receive FDA 510(k) clearance?

Titan 3 Low Speed Angle Attachments received FDA 510(k) clearance on 2017-01-19, under 510(k) number K162397.

Who is the listed applicant for Titan 3 Low Speed Angle Attachments?

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

What is the FDA product code for Titan 3 Low Speed Angle Attachments?

The FDA product code for Titan 3 Low Speed Angle Attachments is EGS.

Other records listing Dentalez, Inc. 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.

K192412SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece K173465Concentrix MX-AC High-Speed Handpiece K153411430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece

Related Devices (Code: EGS)

K251869Disposable Prophy Angle (3399-60, 3399-090, 3399-105)Premium Plus (Dongguan) Limited K240950Disposable Prophy AnglePacific Care Limited K240183Star E900 Handpiece SeriesDentalez, Inc., Stardental Division K230106General Cutting StraightNakanishi, Inc.K222518FX ContraNakanishi, Inc.K220874Smooth Drive contra angle and straight handpiecesLares Research

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.