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FDA 510(k)

PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE

K-Number: K990646 · 1999-03-19

ApplicantNsk Nakanishi, Inc.
Decision Date1999-03-19
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE 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 1999-03-19 under 510(k) number K990646. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE?

PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE is a medical device that received FDA 510(k) clearance on 1999-03-19. The listed applicant is Nsk Nakanishi, Inc.. The 510(k) number is K990646.

When did PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE receive FDA 510(k) clearance?

PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE received FDA 510(k) clearance on 1999-03-19, under 510(k) number K990646.

Who is the listed applicant for PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE?

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 PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE?

The FDA product code for PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE is EKX.

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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.)K980162MACH-SIGMA HANDPIECE, ULTRAPUSHK972924SURGIC II IMPLANT CONTROL UNIT

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Related Devices (Code: EKX)

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.

K261987Reusable SmartPegOsstell ABK252223Alpha Endo Handpiece (Alpha Endo)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K251597InnerView SystemPerimetrics, Inc.K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L.K242514Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)Shenzhen Rogin Medical Co., Ltd.K241065ChecQ (AC100)Dentis 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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