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FDA 510(k)

maxFit II Dental Implant System

K-Number: K151588 · 2016-04-25

ApplicantTaiwan Implant Technology Company, Ltd.
Decision Date2016-04-25
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

maxFit II Dental Implant System is a medical device manufactured by Taiwan Implant Technology Company, Ltd.. It received FDA 510(k) clearance on 2016-04-25 under approval number K151588. 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 maxFit II Dental Implant System?

maxFit II Dental Implant System is a medical device that received FDA 510(k) clearance on 2016-04-25. It is manufactured by Taiwan Implant Technology Company, Ltd.. The 510(k) number is K151588.

When was maxFit II Dental Implant System approved by the FDA?

maxFit II Dental Implant System received FDA 510(k) clearance on 2016-04-25, under approval number K151588.

What company makes maxFit II Dental Implant System?

maxFit II Dental Implant System is manufactured by Taiwan Implant Technology Company, Ltd..

What is the FDA product code for maxFit II Dental Implant System?

The FDA product code for maxFit II Dental Implant System is DZE.

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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)

Related Devices (Code: DZE)

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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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