Home / 510(k) Clearances / K990954

510(k) K990954

ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET by Nsk Nakanishi, Inc. — Product Code EBW

K990954 is an FDA 510(k) premarket notification submitted by Nsk Nakanishi, Inc. for the device "ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET". The FDA issued a decision of Substantially Equivalent on June 9, 1999. The device falls under product code EBW (Controller, Foot, Handpiece And Cord), a Class I device regulated under 21 CFR 872.4200. Nsk Nakanishi, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1999
Date Received
March 22, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Foot, Handpiece And Cord
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by Nsk Nakanishi, Inc.

  • K991701 — MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (August 10, 1999)
  • K991021 — SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MO (June 23, 1999)
  • K990682 — PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RP (March 24, 1999)
  • K990646 — PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE (March 19, 1999)
  • K980162 — MACH-SIGMA HANDPIECE, ULTRAPUSH (June 5, 1998)
  • K972924 — SURGIC II IMPLANT CONTROL UNIT (October 30, 1997)
  • K972569 — E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION (October 8, 1997)
  • K971774 — NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION (June 20, 1997)
  • K970953 — E-TYPE SPEED REDUCER CONTRA ANGLE (April 15, 1997)
  • K962542 — AIR MOTOR HANDPIECE TN-102 (September 24, 1996)

Other clearances for product code EBW

  • K251407 — Motor Handpiece and Control Unit (SDI10) (January 30, 2026)
  • K251701 — Star E900 Electric System (January 12, 2026)
  • K251811 — Motor and Apex Module (MaAM) (August 25, 2025)
  • K231562 — ELEC ENGINE (Model: ISE-170L) (July 18, 2025)
  • K242646 — Dental Implant Unit (April 11, 2025)
  • K233288 — NLZ Built-In Motor System (June 24, 2024)
  • K233117 — Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) (June 20, 2024)
  • K230895 — CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3 (April 1, 2024)
  • K231864 — Fiber Optic Brushless Electronic Micromotor, model: iM100 (March 11, 2024)
  • K211358 — Implanter incl. Accessories (November 21, 2022)

FDA data resources