FDA 510(k)

SureSmile 软件

K号: K253565 · 2026-03-04

决定日期2026-03-04

产品代码PNN

咨询委员会DE

决定Substantially Equivalent

器械摘要

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.

常见问题

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.

列明Dentsply Sirona, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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