FDA 510(k)

HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE

K-Number: K080682 · 2008-09-11

ApplicantHandpiece Headquarters, Inc. - Hpr, Inc.

Decision Date2008-09-11

Product CodeEFB

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Handpiece Headquarters, Inc. - Hpr, Inc.. It received FDA 510(k) clearance on 2008-09-11 under 510(k) number K080682. 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 HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE?

HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE is a medical device that received FDA 510(k) clearance on 2008-09-11. The listed applicant is Handpiece Headquarters, Inc. - Hpr, Inc.. The 510(k) number is K080682.

When did HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE receive FDA 510(k) clearance?

HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE received FDA 510(k) clearance on 2008-09-11, under 510(k) number K080682.

Who is the listed applicant for HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE?

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

What is the FDA product code for HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE?

The FDA product code for HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE is EFB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Handpiece Headquarters, Inc. - Hpr, Inc. as applicant

K113674SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT

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.