Home / 510(k) Clearances / K013185

510(k) K013185

TCM ENDO III by NOUVAG AG — Product Code EFA

K013185 is an FDA 510(k) premarket notification submitted by NOUVAG AG for the device "TCM ENDO III". The FDA issued a decision of Substantially Equivalent on November 28, 2001. The device falls under product code EFA (Handpiece, Belt And/Or Gear Driven, Dental), a Class I device regulated under 21 CFR 872.4200. NOUVAG AG has at least 10 other 510(k) clearances on record.

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

  • K254135 — LipoSurg ARTIST (September 5, 2026)
  • 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)

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