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FDA 510(k)

ATHENA HIGH SPEED HANDPIECE

K-Number: K925678 · 1994-12-15

ApplicantAthena Technology, Inc.
Decision Date1994-12-15
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ATHENA HIGH SPEED HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Athena Technology, Inc.. It received FDA 510(k) clearance on 1994-12-15 under 510(k) number K925678. 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 ATHENA HIGH SPEED HANDPIECE?

ATHENA HIGH SPEED HANDPIECE is a medical device that received FDA 510(k) clearance on 1994-12-15. The listed applicant is Athena Technology, Inc.. The 510(k) number is K925678.

When did ATHENA HIGH SPEED HANDPIECE receive FDA 510(k) clearance?

ATHENA HIGH SPEED HANDPIECE received FDA 510(k) clearance on 1994-12-15, under 510(k) number K925678.

Who is the listed applicant for ATHENA HIGH SPEED HANDPIECE?

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

What is the FDA product code for ATHENA HIGH SPEED HANDPIECE?

The FDA product code for ATHENA HIGH SPEED 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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Other records listing Athena Technology, 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.

K974670ATHENA 1:1 CONTRA ANGLE, ATHENA 4:1 CONTRA ANGLE, ATHENA 16:1 CONTRA ANGLE, ATHENA 64:1 CONTRA ANGLE, ATHENA 16-: CONTREK974671ATHENA 20R S TYPE SLOW SPEED HANDPIECE MOTOR

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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