Primevision 3D
K-Number: K253959 · 2026-02-05
ApplicantDentsply Sirona
Decision Date2026-02-05
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Primevision 3D is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2026-02-05 under approval number K253959. 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 Primevision 3D?
Primevision 3D is a medical device that received FDA 510(k) clearance on 2026-02-05. It is manufactured by Dentsply Sirona. The 510(k) number is K253959.
When was Primevision 3D approved by the FDA?
Primevision 3D received FDA 510(k) clearance on 2026-02-05, under approval number K253959.
What company makes Primevision 3D?
Primevision 3D is manufactured by Dentsply Sirona.
What is the FDA product code for Primevision 3D?
The FDA product code for Primevision 3D 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.