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FDA 510(k)

BioClean Implant Restorative System

K-Number: K222984 · 2022-12-29

ApplicantBioclean Dental, LLC
Decision Date2022-12-29
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BioClean Implant Restorative System is a medical device manufactured by Bioclean Dental, LLC. It received FDA 510(k) clearance on 2022-12-29 under approval number K222984. 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 BioClean Implant Restorative System?

BioClean Implant Restorative System is a medical device that received FDA 510(k) clearance on 2022-12-29. It is manufactured by Bioclean Dental, LLC. The 510(k) number is K222984.

When was BioClean Implant Restorative System approved by the FDA?

BioClean Implant Restorative System received FDA 510(k) clearance on 2022-12-29, under approval number K222984.

What company makes BioClean Implant Restorative System?

BioClean Implant Restorative System is manufactured by Bioclean Dental, LLC.

What is the FDA product code for BioClean Implant Restorative System?

The FDA product code for BioClean Implant Restorative System 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)

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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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