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FDA 510(k)

GOLD AIR, GOLD LIGHT

K-Number: K854645 · 1986-03-12

ApplicantAlpine Dental Equipment Co.
Decision Date1986-03-12
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GOLD AIR, GOLD LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Alpine Dental Equipment Co.. It received FDA 510(k) clearance on 1986-03-12 under 510(k) number K854645. 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 GOLD AIR, GOLD LIGHT?

GOLD AIR, GOLD LIGHT is a medical device that received FDA 510(k) clearance on 1986-03-12. The listed applicant is Alpine Dental Equipment Co.. The 510(k) number is K854645.

When did GOLD AIR, GOLD LIGHT receive FDA 510(k) clearance?

GOLD AIR, GOLD LIGHT received FDA 510(k) clearance on 1986-03-12, under 510(k) number K854645.

Who is the listed applicant for GOLD AIR, GOLD LIGHT?

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

What is the FDA product code for GOLD AIR, GOLD LIGHT?

The FDA product code for GOLD AIR, GOLD LIGHT is EFB.

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Other records listing Alpine Dental Equipment Co. 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.

K880475SKEMA (DENTAL UNIT)K880474AREA (DENTAL CHAIR)K854647POLO DENTAL UNITK854643SOLARK854642SOLAR CARTK854641SOLAR F

View all 10 devices →

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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