Orthophos S
K-Number: K191616 · 2019-07-16
ApplicantDentsply Sirona
Decision Date2019-07-16
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Orthophos S is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2019-07-16 under approval number K191616. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Orthophos S?
Orthophos S is a medical device that received FDA 510(k) clearance on 2019-07-16. It is manufactured by Dentsply Sirona. The 510(k) number is K191616.
When was Orthophos S approved by the FDA?
Orthophos S received FDA 510(k) clearance on 2019-07-16, under approval number K191616.
What company makes Orthophos S?
Orthophos S is manufactured by Dentsply Sirona.
What is the FDA product code for Orthophos S?
The FDA product code for Orthophos S is OAS.
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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.