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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2026-02-05 under 510(k) 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. The listed applicant is Dentsply Sirona. The 510(k) number is K253959.

When did Primevision 3D receive FDA 510(k) clearance?

Primevision 3D received FDA 510(k) clearance on 2026-02-05, under 510(k) number K253959.

Who is the listed applicant for Primevision 3D?

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 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.

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