FDA 510(k)

STARCARE HANDPIECE MAINTENANCE UNIT

K-Number: K093072 · 2009-12-28

Decision Date2009-12-28

Product CodeEFB

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

STARCARE HANDPIECE MAINTENANCE UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Dentalez, Inc.. It received FDA 510(k) clearance on 2009-12-28 under 510(k) number K093072. 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 STARCARE HANDPIECE MAINTENANCE UNIT?

STARCARE HANDPIECE MAINTENANCE UNIT is a medical device that received FDA 510(k) clearance on 2009-12-28. The listed applicant is Dentalez, Inc.. The 510(k) number is K093072.

When did STARCARE HANDPIECE MAINTENANCE UNIT receive FDA 510(k) clearance?

STARCARE HANDPIECE MAINTENANCE UNIT received FDA 510(k) clearance on 2009-12-28, under 510(k) number K093072.

Who is the listed applicant for STARCARE HANDPIECE MAINTENANCE UNIT?

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

What is the FDA product code for STARCARE HANDPIECE MAINTENANCE UNIT?

The FDA product code for STARCARE HANDPIECE MAINTENANCE UNIT is EFB.

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Other records listing Dentalez, Inc. as applicant

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Related Devices (Code: EFB)

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 GmbH K240337Dental 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.