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510(k) K213477

Root ZX3 by J. Morita USA, Inc. — Product Code EKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2022
Date Received
October 29, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, And Accessories, Dental
Device Class
Class II
Regulation Number
872.4920
Review Panel
DE
Submission Type

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Other clearances for product code EKZ

  • K071632 — PERFECT TISSUE CONTOURING SYSTEM II (October 18, 2007)
  • K063468 — THE FUGO BLADE FOR DENTISTRY (April 18, 2007)
  • K052622 — MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT (December 9, 2005)
  • K050735 — MC6A (May 23, 2005)
  • K023672 — X O ODONTOSURGE 4 (April 29, 2003)
  • K020080 — BONART ART-E1 ELECTROSURGERY UNIT (February 19, 2002)
  • K001560 — ODONTOSURGE 3 (August 24, 2000)
  • K000768 — WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (April 11, 2000)
  • K982229 — BI-DENT (August 13, 1998)
  • K981390 — ODONTOSURGE 2 (June 11, 1998)