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FDA 510(k)

FAICO Dental Implant System and CAD/CAM Abutments

K-Number: K211871 · 2021-11-18

ApplicantFaico Medical, LLC
Decision Date2021-11-18
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FAICO Dental Implant System and CAD/CAM Abutments is a medical device manufactured by Faico Medical, LLC. It received FDA 510(k) clearance on 2021-11-18 under approval number K211871. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FAICO Dental Implant System and CAD/CAM Abutments?

FAICO Dental Implant System and CAD/CAM Abutments is a medical device that received FDA 510(k) clearance on 2021-11-18. It is manufactured by Faico Medical, LLC. The 510(k) number is K211871.

When was FAICO Dental Implant System and CAD/CAM Abutments approved by the FDA?

FAICO Dental Implant System and CAD/CAM Abutments received FDA 510(k) clearance on 2021-11-18, under approval number K211871.

What company makes FAICO Dental Implant System and CAD/CAM Abutments?

FAICO Dental Implant System and CAD/CAM Abutments is manufactured by Faico Medical, LLC.

What is the FDA product code for FAICO Dental Implant System and CAD/CAM Abutments?

The FDA product code for FAICO Dental Implant System and CAD/CAM Abutments is NHA.

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Faico Medical, LLC

K191997FAICO CMF System K192015Faico Dental Implant System

Related Devices (Code: NHA)

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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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