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510(k) K013185

TCM ENDO III by NOUVAG AG — Product Code EFA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2001
Date Received
September 24, 2001
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 NOUVAG AG

  • K080365 — MORCE POWER PLUS AND VARIOCARVE MORCELLATOR (June 29, 2009)
  • K081191 — TCM ENDO 20 (August 7, 2008)
  • K071588 — DISPENSER DP 20 (November 26, 2007)
  • K042822 — TCM ENDO V, MODEL 1534 (December 22, 2004)
  • K042943 — NOUVAG AG - VACUSON 40 AND VACUSON 60 (December 17, 2004)
  • K042434 — MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55 (November 3, 2004)
  • K022505 — CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, (October 1, 2003)
  • K000710 — MD 10, SEM, SM 12, CBM (May 11, 2000)
  • K981679 — TCM 3000 AND TCM ENDO (February 9, 1999)
  • K954722 — MICRO-DISPENSER 7000 & MICRODISPENSER 8000 (January 16, 1996)

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)