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510(k) K163239

SMARTmatic by Kaltenbach & Voigt GmbH — Product Code EFA

K163239 is an FDA 510(k) premarket notification submitted by Kaltenbach & Voigt GmbH for the device "SMARTmatic". The FDA issued a decision of Substantially Equivalent on March 17, 2017. The device falls under product code EFA (Handpiece, Belt And/Or Gear Driven, Dental), a Class I device regulated under 21 CFR 872.4200. Kaltenbach & Voigt GmbH has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2017
Date Received
November 18, 2016
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 Kaltenbach & Voigt GmbH

  • K182712 — DEXIS CariVu 3-in-1 by KaVo (November 23, 2019)
  • K181110 — PROPHYflex 4 (April 10, 2019)
  • K161488 — ESTETICA Dental Treatment Unit and Accessories (December 8, 2016)
  • K143465 — MASTERmatic LUX (April 9, 2015)
  • K140308 — MASTERSURG / EXPERTSURG (August 15, 2014)
  • K130560 — MASTERTORQUE LUX 8900 L (September 27, 2013)
  • K123402 — DIAGNOCAM (September 24, 2013)
  • K103027 — ELECTROTORQUE TLC (August 19, 2011)

Other clearances for product code EFA

  • K192809 — Dental Handpiece (August 25, 2020)
  • 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)
  • K061701 — HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) (August 25, 2006)

FDA data resources