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FDA 510(k)

HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE

K-Number: K902402 · 1990-08-29

ApplicantDentalez Group
Decision Date1990-08-29
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HIGH SPEED NON-FIBER OPTIC SWIVEL 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 1990-08-29 under 510(k) number K902402. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE?

HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE is a medical device that received FDA 510(k) clearance on 1990-08-29. The listed applicant is Dentalez Group. The 510(k) number is K902402.

When did HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE receive FDA 510(k) clearance?

HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE received FDA 510(k) clearance on 1990-08-29, under 510(k) number K902402.

Who is the listed applicant for HIGH SPEED NON-FIBER OPTIC SWIVEL 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 HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE?

The FDA product code for HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE is EBF.

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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: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, Inc.

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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