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510(k) K070084

MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL by Est. Anthogyr — Product Code EFA

K070084 is an FDA 510(k) premarket notification submitted by Est. Anthogyr for the device "MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL". The FDA issued a decision of Substantially Equivalent on March 8, 2007. The device falls under product code EFA (Handpiece, Belt And/Or Gear Driven, Dental), a Class I device regulated under 21 CFR 872.4200. Est. Anthogyr has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2007
Date Received
January 9, 2007
Clearance Type
Special
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 Est. Anthogyr

  • K060317 — ANTHOGYR CONTRA ANGLES AND HANDPIECES (April 28, 2006)
  • K020431 — FIBIOCORE (July 3, 2002)

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

FDA data resources