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FDA 510(k)

PRODRIVE LINE OF DENTAL HANDPIECES

K-Number: K090369 · 2009-02-27

ApplicantProdrive Systems, Inc.
Decision Date2009-02-27
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRODRIVE LINE OF DENTAL HANDPIECES 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 2009-02-27 under 510(k) number K090369. 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 LINE OF DENTAL HANDPIECES?

PRODRIVE LINE OF DENTAL HANDPIECES is a medical device that received FDA 510(k) clearance on 2009-02-27. The listed applicant is Prodrive Systems, Inc.. The 510(k) number is K090369.

When did PRODRIVE LINE OF DENTAL HANDPIECES receive FDA 510(k) clearance?

PRODRIVE LINE OF DENTAL HANDPIECES received FDA 510(k) clearance on 2009-02-27, under 510(k) number K090369.

Who is the listed applicant for PRODRIVE LINE OF DENTAL HANDPIECES?

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 LINE OF DENTAL HANDPIECES?

The FDA product code for PRODRIVE LINE OF DENTAL HANDPIECES 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.

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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.

K073353DO-ALL DENTAL HANDPIECE LUBRICANTK062219PRODRIVE SYSTEMS REPLACEMENT TURBINE

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.K251389High speed air turbine handpieceFoshan Topmed Dental 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.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

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