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510(k) K093894

ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE by Anthogyr — Product Code EFA

K093894 is an FDA 510(k) premarket notification submitted by Anthogyr for the device "ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE". The FDA issued a decision of Substantially Equivalent on March 3, 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. Anthogyr has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2010
Date Received
December 18, 2009
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 Anthogyr

  • K231072 — Anthogyr FlexiBase® titanium bases for Axiom® BL (January 4, 2024)
  • K233264 — Anthogyr INTEGRAL Guided Surgery Cassettes (December 22, 2023)
  • K230104 — Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL (October 16, 2023)
  • K230680 — Anthogyr Surgical Cassettes (July 11, 2023)
  • K161177 — Axiom PX (June 15, 2017)
  • K160730 — Instrument kits (April 27, 2017)
  • K141450 — AXIOM 2.8 (September 17, 2014)
  • K131066 — AXIOM REG (February 21, 2014)
  • K111532 — MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE (October 7, 2011)
  • K102241 — ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT (March 23, 2011)

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)
  • 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