Home / 510(k) Clearances / K161177

510(k) K161177

Axiom PX by Anthogyr Sas — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2017
Date Received
April 26, 2016
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

Other clearances by Anthogyr Sas

  • 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)
  • 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)
  • K101913 — ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM (March 11, 2011)

Other clearances for product code DZE

  • K252168 — Straumann® BLC Implants - Indication Widening (March 10, 2026)
  • K253493 — Dentis SQ-SL AXEL Fixture (March 4, 2026)
  • K252197 — Nobel Biocare S Series Implants (February 18, 2026)
  • K252286 — BIORES Dental Implant System (February 2, 2026)
  • K252585 — ZENEX Implant System_R-System (January 8, 2026)
  • K250476 — NizPlant Dental Implant System (December 23, 2025)
  • K252145 — GEN5™ and GEN5+™ 3.3mmD Dental Implants (December 23, 2025)
  • K251605 — DIMPLO Implant System (December 22, 2025)
  • K252090 — Pterygoid Indication for GM Helix Implants (December 12, 2025)
  • K251129 — S.I.N. Tapered Pro Conical Zygoma Implant System (November 7, 2025)