Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET

K-Number: K990954 · 1999-06-09

ApplicantNsk Nakanishi, Inc.
Decision Date1999-06-09
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET 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 1999-06-09 under 510(k) number K990954. 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 ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET?

ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET is a medical device that received FDA 510(k) clearance on 1999-06-09. The listed applicant is Nsk Nakanishi, Inc.. The 510(k) number is K990954.

When did ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET receive FDA 510(k) clearance?

ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET received FDA 510(k) clearance on 1999-06-09, under 510(k) number K990954.

Who is the listed applicant for ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET?

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 ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET?

The FDA product code for ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET is EBW.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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-NLK990682PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.)K990646PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATEK980162MACH-SIGMA HANDPIECE, ULTRAPUSHK972924SURGIC II IMPLANT CONTROL UNIT

View all 13 devices →

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.

↑