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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 the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2020-08-16 under 510(k) 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. The listed applicant is Dentsply Sirona. The 510(k) number is K193408.

When did Sirona Dental CAD/CAM System with CEREC Chairside Software receive FDA 510(k) clearance?

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

Who is the listed applicant for Sirona Dental CAD/CAM System with CEREC Chairside Software?

The FDA 510(k) record lists Dentsply Sirona as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

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Other records listing Dentsply Sirona as applicant

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Related Devices (Code: NHA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC

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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