Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PRODRIVE SYSTEMS REPLACEMENT TURBINE

K-Number: K062219 · 2006-08-04

ApplicantProdrive Systems, Inc.
Decision Date2006-08-04
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRODRIVE SYSTEMS REPLACEMENT TURBINE is the device name listed in this FDA 510(k) record. The listed applicant is Prodrive Systems, Inc.. It received FDA 510(k) clearance on 2006-08-04 under 510(k) number K062219. 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 PRODRIVE SYSTEMS REPLACEMENT TURBINE?

PRODRIVE SYSTEMS REPLACEMENT TURBINE is a medical device that received FDA 510(k) clearance on 2006-08-04. The listed applicant is Prodrive Systems, Inc.. The 510(k) number is K062219.

When did PRODRIVE SYSTEMS REPLACEMENT TURBINE receive FDA 510(k) clearance?

PRODRIVE SYSTEMS REPLACEMENT TURBINE received FDA 510(k) clearance on 2006-08-04, under 510(k) number K062219.

Who is the listed applicant for PRODRIVE SYSTEMS REPLACEMENT TURBINE?

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

What is the FDA product code for PRODRIVE SYSTEMS REPLACEMENT TURBINE?

The FDA product code for PRODRIVE SYSTEMS REPLACEMENT TURBINE 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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Prodrive Systems, Inc. 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.

K090369PRODRIVE LINE OF DENTAL HANDPIECESK073353DO-ALL DENTAL HANDPIECE LUBRICANT

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.

↑