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FDA 510(k)

IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE

K-Number: K972375 · 1997-09-10

ApplicantGlenwood, LLC
Decision Date1997-09-10
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE is the device name listed in this FDA 510(k) record. The listed applicant is Glenwood, LLC. It received FDA 510(k) clearance on 1997-09-10 under 510(k) number K972375. 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 IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE?

IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE is a medical device that received FDA 510(k) clearance on 1997-09-10. The listed applicant is Glenwood, LLC. The 510(k) number is K972375.

When did IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE receive FDA 510(k) clearance?

IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE received FDA 510(k) clearance on 1997-09-10, under 510(k) number K972375.

Who is the listed applicant for IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE?

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

What is the FDA product code for IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE?

The FDA product code for IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE 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 Glenwood, LLC 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.

K972376IMPACT AIR 45 HANDPIECE FOR PERIODONTAL USE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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