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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 the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona, Inc.. It received FDA 510(k) clearance on 2026-03-04 under 510(k) 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. The listed applicant is Dentsply Sirona, Inc.. The 510(k) number is K253565.

When did SureSmile Software receive FDA 510(k) clearance?

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

Who is the listed applicant for SureSmile Software?

The FDA 510(k) record lists Dentsply Sirona, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SureSmile Software?

The FDA product code for SureSmile Software is PNN.

Other records listing Dentsply Sirona, Inc. as applicant

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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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