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FDA 510(k)

Primescan 2

K-Number: K250771 · 2025-08-29

ApplicantDentsply Sirona, Inc.
Decision Date2025-08-29
Product CodeNTK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Primescan 2 is a medical device manufactured by Dentsply Sirona, Inc.. It received FDA 510(k) clearance on 2025-08-29 under approval number K250771. The device is classified under product code NTK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Primescan 2?

Primescan 2 is a medical device that received FDA 510(k) clearance on 2025-08-29. It is manufactured by Dentsply Sirona, Inc.. The 510(k) number is K250771.

When was Primescan 2 approved by the FDA?

Primescan 2 received FDA 510(k) clearance on 2025-08-29, under approval number K250771.

What company makes Primescan 2?

Primescan 2 is manufactured by Dentsply Sirona, Inc..

What is the FDA product code for Primescan 2?

The FDA product code for Primescan 2 is NTK.

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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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