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FDA 510(k)

SureSmile Software

K-Number: K253565 · 2026-03-04

ApplicantDentsply Sirona, Inc.
Decision Date2026-03-04
Product CodePNN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SureSmile Software is a medical device manufactured by Dentsply Sirona, Inc.. It received FDA 510(k) clearance on 2026-03-04 under approval number K253565. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SureSmile Software?

SureSmile Software is a medical device that received FDA 510(k) clearance on 2026-03-04. It is manufactured by Dentsply Sirona, Inc.. The 510(k) number is K253565.

When was SureSmile Software approved by the FDA?

SureSmile Software received FDA 510(k) clearance on 2026-03-04, under approval number K253565.

What company makes SureSmile Software?

SureSmile Software is manufactured by Dentsply Sirona, Inc..

What is the FDA product code for SureSmile Software?

The FDA product code for SureSmile Software is PNN.

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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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