Anthogyr

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
16
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2753-2016Class IIAxiom REG implants Sterile The Axiom REG implants are used as artificial root structures for replJune 20, 2016
Z-2754-2016Class IIAxiom 2.8 implants Sterile The Axiom REG implants are used as artificial root structures for repJune 20, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K231072Anthogyr FlexiBase® titanium bases for Axiom® BLJanuary 4, 2024
K233264Anthogyr INTEGRAL Guided Surgery CassettesDecember 22, 2023
K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLOctober 16, 2023
K230680Anthogyr Surgical CassettesJuly 11, 2023
K161177Axiom PXJune 15, 2017
K160730Instrument kitsApril 27, 2017
K141450AXIOM 2.8September 17, 2014
K131066AXIOM REGFebruary 21, 2014
K111532MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECEOctober 7, 2011
K102241ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNITMarch 23, 2011
K101913ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOMMarch 11, 2011
K093894ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLEMarch 3, 2010
K090676MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLESMay 22, 2009
K040671EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGESDecember 14, 2004
K041279IMPLANTEO IMPLANTOLOGY MOTORSeptember 23, 2004
K040674IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLESJune 30, 2004