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510(k) K213477

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

K213477 is an FDA 510(k) premarket notification submitted by J. Morita USA, Inc. for the device "Root ZX3". The FDA issued a decision of Substantially Equivalent on August 3, 2022. The device falls under product code EKZ (Unit, Electrosurgical, And Accessories, Dental), a Class II device regulated under 21 CFR 872.4920. J. Morita USA, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by J. Morita USA, Inc.

  • K201378 — 3D Accuitomo 150N (February 18, 2021)
  • K190509 — Lubrina 2 (March 4, 2020)
  • K173920 — LS OIL (October 11, 2018)
  • K171012 — Veraview X800 (December 19, 2017)
  • K170275 — Tri Auto ZX2 (September 11, 2017)
  • K120377 — ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A (July 25, 2012)
  • K112665 — TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE (May 4, 2012)
  • K103697 — TORQTECH (January 20, 2012)
  • K090925 — MULTIPLE (APEX LOCATOR), MODEL RCM-7 (November 23, 2009)
  • K091065 — AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4 (October 16, 2009)

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)

FDA data resources