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FDA 510(k)

SURGIC II IMPLANT CONTROL UNIT

K-Number: K972924 · 1997-10-30

ApplicantNsk Nakanishi, Inc.
Decision Date1997-10-30
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SURGIC II IMPLANT CONTROL UNIT 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 1997-10-30 under 510(k) number K972924. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGIC II IMPLANT CONTROL UNIT?

SURGIC II IMPLANT CONTROL UNIT is a medical device that received FDA 510(k) clearance on 1997-10-30. The listed applicant is Nsk Nakanishi, Inc.. The 510(k) number is K972924.

When did SURGIC II IMPLANT CONTROL UNIT receive FDA 510(k) clearance?

SURGIC II IMPLANT CONTROL UNIT received FDA 510(k) clearance on 1997-10-30, under 510(k) number K972924.

Who is the listed applicant for SURGIC II IMPLANT CONTROL UNIT?

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 SURGIC II IMPLANT CONTROL UNIT?

The FDA product code for SURGIC II IMPLANT CONTROL UNIT is EBW.

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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

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Related Devices (Code: EBW)

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.

K251407Motor Handpiece and Control Unit (SDI10)Saeshin Precision Co., Ltd.K251701Star E900 Electric SystemDentalez, Inc., Stardental DivisionK251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc.K231562ELEC ENGINE (Model: ISE-170L)Micro-Nx Co., Ltd.K242646Dental Implant UnitGuilin Aesthedent Medical Instruments Co., Ltd.K233288NLZ Built-In Motor SystemNakanishi, Inc.

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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