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FDA 510(k)

AIR POWERED DENTAL HANDPIECE

K-Number: K781545 · 1978-11-15

ApplicantPromident Mfg., Ltd.
Decision Date1978-11-15
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AIR POWERED DENTAL HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Promident Mfg., Ltd.. It received FDA 510(k) clearance on 1978-11-15 under 510(k) number K781545. 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 AIR POWERED DENTAL HANDPIECE?

AIR POWERED DENTAL HANDPIECE is a medical device that received FDA 510(k) clearance on 1978-11-15. The listed applicant is Promident Mfg., Ltd.. The 510(k) number is K781545.

When did AIR POWERED DENTAL HANDPIECE receive FDA 510(k) clearance?

AIR POWERED DENTAL HANDPIECE received FDA 510(k) clearance on 1978-11-15, under 510(k) number K781545.

Who is the listed applicant for AIR POWERED DENTAL HANDPIECE?

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

What is the FDA product code for AIR POWERED DENTAL HANDPIECE?

The FDA product code for AIR POWERED DENTAL 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.

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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

View on FDA Database →

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

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