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FDA 510(k)

HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE

K-Number: K896361 · 1990-02-02

ApplicantDentalez Group
Decision Date1990-02-02
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE is the device name listed in this FDA 510(k) record. The listed applicant is Dentalez Group. It received FDA 510(k) clearance on 1990-02-02 under 510(k) number K896361. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE?

HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE is a medical device that received FDA 510(k) clearance on 1990-02-02. The listed applicant is Dentalez Group. The 510(k) number is K896361.

When did HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE receive FDA 510(k) clearance?

HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE received FDA 510(k) clearance on 1990-02-02, under 510(k) number K896361.

Who is the listed applicant for HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE?

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 HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE?

The FDA product code for HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE is EFB.

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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: EFB)

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.

K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd.K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)Foshan Topmed Dental Co., Ltd.K251389High speed air turbine handpieceFoshan Topmed Dental Co., Ltd.K242179Synea Fusion Handpieces (Intensiv & Profin)W&H Dentalwerk Bürmoos GmbHK240337Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)Guangdong Jinme Medical Technology Co., Ltd.K241074High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)Foshan Soco Precision Instrument Co., Ltd.

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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