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FDA 510(k)

STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE

K-Number: K960719 · 1996-03-28

ApplicantDentalez Group
Decision Date1996-03-28
Product CodeEFA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Dentalez Group. It received FDA 510(k) clearance on 1996-03-28 under 510(k) number K960719. The device is classified under product code EFA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE?

STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE is a medical device that received FDA 510(k) clearance on 1996-03-28. The listed applicant is Dentalez Group. The 510(k) number is K960719.

When did STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE receive FDA 510(k) clearance?

STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE received FDA 510(k) clearance on 1996-03-28, under 510(k) number K960719.

Who is the listed applicant for STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE?

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 STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE?

The FDA product code for STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE is EFA.

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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 SYSTEMK983574STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTSK982593LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIEK960507STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES

View all 13 devices →

Related Devices (Code: EFA)

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.

K192809Dental HandpieceMicro-Nx Co., Ltd.K163239SMARTmaticKaltenbach & Voigt GmbHK101172RDT3 HANDPIECE HEAD MODEL RDT3Redent Nova, Ltd.K093894ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLEAnthogyrK092446INTRA LUX HEAD 3 LDSYKaltenbach & Voigt GmbH & Co.K090055LOW & HIGH SPEED KITDpm USA Corp.

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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