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FDA 510(k)

ENDO-EZE MOTOR AND HANDPIECE

K-Number: K992380 · 1999-10-13

ApplicantUltradent Products, Inc.
Decision Date1999-10-13
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENDO-EZE MOTOR AND HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 1999-10-13 under 510(k) number K992380. 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 ENDO-EZE MOTOR AND HANDPIECE?

ENDO-EZE MOTOR AND HANDPIECE is a medical device that received FDA 510(k) clearance on 1999-10-13. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K992380.

When did ENDO-EZE MOTOR AND HANDPIECE receive FDA 510(k) clearance?

ENDO-EZE MOTOR AND HANDPIECE received FDA 510(k) clearance on 1999-10-13, under 510(k) number K992380.

Who is the listed applicant for ENDO-EZE MOTOR AND HANDPIECE?

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

What is the FDA product code for ENDO-EZE MOTOR AND HANDPIECE?

The FDA product code for ENDO-EZE MOTOR AND HANDPIECE is EFB.

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Related Devices (Code: EFB)

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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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