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510(k) K231072

Anthogyr FlexiBase® titanium bases for Axiom® BL by Anthogyr — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2024
Date Received
April 14, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Abutment, Implant, Dental, Endosseous
Device Class
Class II
Regulation Number
872.3630
Review Panel
DE
Submission Type

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

Other clearances by Anthogyr

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

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