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FDA 510(k)

Keystone Dental XL Dental Implant System

K-Number: K201334 · 2020-08-18

ApplicantKeystone Dental, Inc.
Decision Date2020-08-18
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Keystone Dental XL Dental Implant System is a medical device manufactured by Keystone Dental, Inc.. It received FDA 510(k) clearance on 2020-08-18 under approval number K201334. 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 Keystone Dental XL Dental Implant System?

Keystone Dental XL Dental Implant System is a medical device that received FDA 510(k) clearance on 2020-08-18. It is manufactured by Keystone Dental, Inc.. The 510(k) number is K201334.

When was Keystone Dental XL Dental Implant System approved by the FDA?

Keystone Dental XL Dental Implant System received FDA 510(k) clearance on 2020-08-18, under approval number K201334.

What company makes Keystone Dental XL Dental Implant System?

Keystone Dental XL Dental Implant System is manufactured by Keystone Dental, Inc..

What is the FDA product code for Keystone Dental XL Dental Implant System?

The FDA product code for Keystone Dental XL 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)

Other Devices by Keystone Dental, Inc.

K221381KDG Abutments K223814Genesis ACTIVE Implant System K240966Prima Plus Conical Implant System

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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