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FDA 510(k)

Sirona Dental CAD/CAM System with CEREC Chairside Software

K-Number: K193408 · 2020-08-16

ApplicantDentsply Sirona
Decision Date2020-08-16
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Sirona Dental CAD/CAM System with CEREC Chairside Software is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2020-08-16 under approval number K193408. 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 Sirona Dental CAD/CAM System with CEREC Chairside Software?

Sirona Dental CAD/CAM System with CEREC Chairside Software is a medical device that received FDA 510(k) clearance on 2020-08-16. It is manufactured by Dentsply Sirona. The 510(k) number is K193408.

When was Sirona Dental CAD/CAM System with CEREC Chairside Software approved by the FDA?

Sirona Dental CAD/CAM System with CEREC Chairside Software received FDA 510(k) clearance on 2020-08-16, under approval number K193408.

What company makes Sirona Dental CAD/CAM System with CEREC Chairside Software?

Sirona Dental CAD/CAM System with CEREC Chairside Software is manufactured by Dentsply Sirona.

What is the FDA product code for Sirona Dental CAD/CAM System with CEREC Chairside Software?

The FDA product code for Sirona Dental CAD/CAM System with CEREC Chairside Software is NHA.

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Related PubMed Literature

PMID: 38767890 Strengthening the use of artificial intelligence within healthcare delivery organizations: balancing regulatory compliance and patient safety. Journal of the American Medical Informatics Association : JAMIA (2024) PMID: 35047938 Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Frontiers in medical technology (2021) PMID: 37181834 Methodology for Conducting Post-Marketing Surveillance of Software as a Medical Device Based on Artificial Intelligence Technologies. Sovremennye tekhnologii v meditsine (2022)

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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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