Decision Date1996-09-24
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
AIR MOTOR HANDPIECE TN-102 is the device name listed in this FDA 510(k) record. The listed applicant is Nsk Nakanishi, Inc.. It received FDA 510(k) clearance on 1996-09-24 under 510(k) number K962542. 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 AIR MOTOR HANDPIECE TN-102?
AIR MOTOR HANDPIECE TN-102 is a medical device that received FDA 510(k) clearance on 1996-09-24. The listed applicant is Nsk Nakanishi, Inc.. The 510(k) number is K962542.
When did AIR MOTOR HANDPIECE TN-102 receive FDA 510(k) clearance?
AIR MOTOR HANDPIECE TN-102 received FDA 510(k) clearance on 1996-09-24, under 510(k) number K962542.
Who is the listed applicant for AIR MOTOR HANDPIECE TN-102?
The FDA 510(k) record lists Nsk Nakanishi, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AIR MOTOR HANDPIECE TN-102?
The FDA product code for AIR MOTOR HANDPIECE TN-102 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.
Other records listing Nsk Nakanishi, 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.
K991701MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD)K991021SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NLK990954ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SETK990682PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.)K990646PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATEK980162MACH-SIGMA HANDPIECE, ULTRAPUSH View all 13 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.