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510(k) K101172

RDT3 HANDPIECE HEAD MODEL RDT3 by Redent Nova, Ltd. — Product Code EFA

K101172 is an FDA 510(k) premarket notification submitted by Redent Nova, Ltd. for the device "RDT3 HANDPIECE HEAD MODEL RDT3". The FDA issued a decision of Substantially Equivalent on July 27, 2010. The device falls under product code EFA (Handpiece, Belt And/Or Gear Driven, Dental), a Class I device regulated under 21 CFR 872.4200. Redent Nova, Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2010
Date Received
April 26, 2010
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 Redent Nova, Ltd.

  • K100606 — VATEA ENDONTIC IRRIGATION SYSTEM (May 28, 2010)

Other clearances for product code EFA

  • K192809 — Dental Handpiece (August 25, 2020)
  • K163239 — SMARTmatic (March 17, 2017)
  • K143465 — MASTERmatic LUX (April 9, 2015)
  • 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