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FDA 510(k)

AIRLIGHT DENTAL HANDPIECE

K-Number: K112623 · 2011-12-16

ApplicantBeyes Dental Canada, Inc.
Decision Date2011-12-16
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AIRLIGHT DENTAL HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Beyes Dental Canada, Inc.. It received FDA 510(k) clearance on 2011-12-16 under 510(k) number K112623. 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 AIRLIGHT DENTAL HANDPIECE?

AIRLIGHT DENTAL HANDPIECE is a medical device that received FDA 510(k) clearance on 2011-12-16. The listed applicant is Beyes Dental Canada, Inc.. The 510(k) number is K112623.

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

AIRLIGHT DENTAL HANDPIECE received FDA 510(k) clearance on 2011-12-16, under 510(k) number K112623.

Who is the listed applicant for AIRLIGHT DENTAL HANDPIECE?

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

What is the FDA product code for AIRLIGHT DENTAL HANDPIECE?

The FDA product code for AIRLIGHT 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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Other records listing Beyes Dental Canada, 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.

K112869EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400

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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