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510(k) K092446

INTRA LUX HEAD 3 LDSY by Kaltenbach & Voigt GmbH & Co. — Product Code EFA

K092446 is an FDA 510(k) premarket notification submitted by Kaltenbach & Voigt GmbH & Co. for the device "INTRA LUX HEAD 3 LDSY". The FDA issued a decision of Substantially Equivalent on November 3, 2009. 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 & Co. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2009
Date Received
August 10, 2009
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 & Co.

  • K080677 — COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE (June 6, 2008)

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)
  • 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