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510(k) K061701

HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) by J. Morita USA, Inc. — Product Code EFA

K061701 is an FDA 510(k) premarket notification submitted by J. Morita USA, Inc. for the device "HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H)". The FDA issued a decision of Substantially Equivalent on August 25, 2006. The device falls under product code EFA (Handpiece, Belt And/Or Gear Driven, Dental), a Class I device regulated under 21 CFR 872.4200. J. Morita USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2006
Date Received
June 16, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Belt And/Or Gear Driven, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by J. Morita USA, Inc.

  • K213477 — Root ZX3 (August 3, 2022)
  • 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)

Other clearances for product code EFA

  • K192809 — Dental Handpiece (August 25, 2020)
  • K163239 — SMARTmatic (March 17, 2017)
  • K143465 — MASTERmatic LUX (April 9, 2015)
  • K101172 — RDT3 HANDPIECE HEAD MODEL RDT3 (July 27, 2010)
  • K093894 — ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE (March 3, 2010)
  • K092446 — INTRA LUX HEAD 3 LDSY (November 3, 2009)
  • K090055 — LOW & HIGH SPEED KIT (October 27, 2009)
  • K092412 — STRONG IMPLANT HANDPIECES (September 3, 2009)
  • K090676 — MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES (May 22, 2009)
  • K070084 — MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL (March 8, 2007)

FDA data resources