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FDA 510(k)

ORALUBE

K-Number: K000847 · 2000-09-27

ApplicantOrasystems
Decision Date2000-09-27
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORALUBE is the device name listed in this FDA 510(k) record. The listed applicant is Orasystems. It received FDA 510(k) clearance on 2000-09-27 under 510(k) number K000847. 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 ORALUBE?

ORALUBE is a medical device that received FDA 510(k) clearance on 2000-09-27. The listed applicant is Orasystems. The 510(k) number is K000847.

When did ORALUBE receive FDA 510(k) clearance?

ORALUBE received FDA 510(k) clearance on 2000-09-27, under 510(k) number K000847.

Who is the listed applicant for ORALUBE?

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

What is the FDA product code for ORALUBE?

The FDA product code for ORALUBE 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 Orasystems 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.

K000846TKD SCALERSK000848TDK HANDPIECES

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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