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FDA 510(k)

STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS

K-Number: K983574 · 1999-01-08

ApplicantDentalez Group
Decision Date1999-01-08
Product CodeEGS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Dentalez Group. It received FDA 510(k) clearance on 1999-01-08 under 510(k) number K983574. 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 STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS?

STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS is a medical device that received FDA 510(k) clearance on 1999-01-08. The listed applicant is Dentalez Group. The 510(k) number is K983574.

When did STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS receive FDA 510(k) clearance?

STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS received FDA 510(k) clearance on 1999-01-08, under 510(k) number K983574.

Who is the listed applicant for STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS?

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

What is the FDA product code for STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS?

The FDA product code for STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS is EGS.

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Other records listing Dentalez Group 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.

K030133SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECEK021378PORTABLE HDX INTRAORAL X-RAYK990844STARDENTAL AXCS STERILE WATER SYSTEMK982593LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIEK960719STAR DENTAL 430 SERIES HIGH SPEED HANDPIECEK960260STAR TITAN SERIES MOTORS & ATTACHMENTS

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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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