Home / 510(k) Clearances / K991701

510(k) K991701

MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD) by Nsk Nakanishi, Inc. — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1999
Date Received
May 19, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by Nsk Nakanishi, Inc.

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  • 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)

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