Decision Date1989-06-23
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
IMD 7GX is the device name listed in this FDA 510(k) record. The listed applicant is Medical Dental Technology Co.. It received FDA 510(k) clearance on 1989-06-23 under 510(k) number K885115. 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 IMD 7GX?
IMD 7GX is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is Medical Dental Technology Co.. The 510(k) number is K885115.
When did IMD 7GX receive FDA 510(k) clearance?
IMD 7GX received FDA 510(k) clearance on 1989-06-23, under 510(k) number K885115.
Who is the listed applicant for IMD 7GX?
The FDA 510(k) record lists Medical Dental Technology Co. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for IMD 7GX?
The FDA product code for IMD 7GX is EFB.
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.