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FDA 510(k)

Synea Fusion Handpieces (Intensiv & Profin)

K-Number: K242179 · 2025-02-28

ApplicantW&H Dentalwerk Bürmoos GmbH
Decision Date2025-02-28
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Synea Fusion Handpieces (Intensiv & Profin) is the device name listed in this FDA 510(k) record. The listed applicant is W&H Dentalwerk Bürmoos GmbH. It received FDA 510(k) clearance on 2025-02-28 under 510(k) number K242179. 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 Synea Fusion Handpieces (Intensiv & Profin)?

Synea Fusion Handpieces (Intensiv & Profin) is a medical device that received FDA 510(k) clearance on 2025-02-28. The listed applicant is W&H Dentalwerk Bürmoos GmbH. The 510(k) number is K242179.

When did Synea Fusion Handpieces (Intensiv & Profin) receive FDA 510(k) clearance?

Synea Fusion Handpieces (Intensiv & Profin) received FDA 510(k) clearance on 2025-02-28, under 510(k) number K242179.

Who is the listed applicant for Synea Fusion Handpieces (Intensiv & Profin)?

The FDA 510(k) record lists W&H Dentalwerk Bürmoos GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synea Fusion Handpieces (Intensiv & Profin)?

The FDA product code for Synea Fusion Handpieces (Intensiv & Profin) is EFB.

Other records listing W&H Dentalwerk Bürmoos GmbH 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.

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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.

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.K240337Dental 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.K241880Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)Nakanishi, Inc.K233122High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)Litu Tech , Ltd.

Official Source

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