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FDA 510(k)

TUBING HANDPIECE REPLACEMENT

K-Number: K854697 · 1986-03-06

ApplicantAlmore Intl., Inc.
Decision Date1986-03-06
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TUBING HANDPIECE REPLACEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Almore Intl., Inc.. It received FDA 510(k) clearance on 1986-03-06 under 510(k) number K854697. 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 TUBING HANDPIECE REPLACEMENT?

TUBING HANDPIECE REPLACEMENT is a medical device that received FDA 510(k) clearance on 1986-03-06. The listed applicant is Almore Intl., Inc.. The 510(k) number is K854697.

When did TUBING HANDPIECE REPLACEMENT receive FDA 510(k) clearance?

TUBING HANDPIECE REPLACEMENT received FDA 510(k) clearance on 1986-03-06, under 510(k) number K854697.

Who is the listed applicant for TUBING HANDPIECE REPLACEMENT?

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

What is the FDA product code for TUBING HANDPIECE REPLACEMENT?

The FDA product code for TUBING HANDPIECE REPLACEMENT is EFB.

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Other records listing Almore Intl., 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.

K862851ALMORE FACE MASKK854692MONARCH II BLEACHING INSTRUMENTK854696OP II VISIBLE LIGHT CURING SYSTEMK854690DIAMONDS BURS-COMPOSIT FINISHINGK854691DIAMOND BURS-HANDPIECEK854700EZ-ON TUBING CONDITIONER (LUBRICANT)

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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.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

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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