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510(k) K090055

LOW & HIGH SPEED KIT by Dpm USA Corp. — Product Code EFA

K090055 is an FDA 510(k) premarket notification submitted by Dpm USA Corp. for the device "LOW & HIGH SPEED KIT". The FDA issued a decision of Substantially Equivalent on October 27, 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. Dpm USA Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2009
Date Received
January 8, 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 Dpm USA Corp.

  • K083059 — AIR SONIC SCALER (January 30, 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)
  • 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