Simplant Digital Guide
K-Number: K193405 · 2020-09-02
ApplicantDentsply Sirona
Decision Date2020-09-02
Product CodeNDP
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Simplant Digital Guide is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2020-09-02 under approval number K193405. The device is classified under product code NDP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Simplant Digital Guide?
Simplant Digital Guide is a medical device that received FDA 510(k) clearance on 2020-09-02. It is manufactured by Dentsply Sirona. The 510(k) number is K193405.
When was Simplant Digital Guide approved by the FDA?
Simplant Digital Guide received FDA 510(k) clearance on 2020-09-02, under approval number K193405.
What company makes Simplant Digital Guide?
Simplant Digital Guide is manufactured by Dentsply Sirona.
What is the FDA product code for Simplant Digital Guide?
The FDA product code for Simplant Digital Guide is NDP.
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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.