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FDA 510(k)

Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL

K-Number: K230104 · 2023-10-16

ApplicantAnthogyr
Decision Date2023-10-16
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL is a medical device manufactured by Anthogyr. It received FDA 510(k) clearance on 2023-10-16 under approval number K230104. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL?

Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL is a medical device that received FDA 510(k) clearance on 2023-10-16. It is manufactured by Anthogyr. The 510(k) number is K230104.

When was Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL approved by the FDA?

Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL received FDA 510(k) clearance on 2023-10-16, under approval number K230104.

What company makes Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL?

Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL is manufactured by Anthogyr.

What is the FDA product code for Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL?

The FDA product code for Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL is DZE.

Related Clinical Trials

NCT05362370 Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness ACTIVE_NOT_RECRUITING NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED NCT07574164 Closed-loop TMS for Tremor RECRUITING NCT05615844 Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy RECRUITING NCT05190978 Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction RECRUITING NCT03908177 Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national RCT. COMPLETED

Related PubMed Literature

PMID: 42127028 Proposed standards for prosthetic foot reuse and considerations for donation of used prosthetic feet to low-and middle-income countries. PLOS global public health (2026) PMID: 41153261 From Lab to Clinic: Artificial Intelligence with Spectroscopic Liquid Biopsies. Diagnostics (Basel, Switzerland) (2025)

Other Devices by Anthogyr

K160730Instrument kits K233264Anthogyr INTEGRAL Guided Surgery Cassettes K230680Anthogyr Surgical Cassettes K231072Anthogyr FlexiBase® titanium bases for Axiom® BL

Related Devices (Code: DZE)

K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. K163043Zeramex P6 Dental Implant SystemDentalpoint AG K161497Dental Implants and AbutmentsDitron Precision, Ltd. K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc. K151970KJ Mini Implant SystemKj Meditech Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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