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510(k) K962543

ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU by Nsk Nakanishi, Inc. — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1996
Date Received
June 28, 1996
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

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  • 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)

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