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FDA 510(k)

Celebrace Software

K-Number: K253343 · 2025-12-29

ApplicantCelebrace
Decision Date2025-12-29
Product CodePNN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Celebrace Software is the device name listed in this FDA 510(k) record. The listed applicant is Celebrace. It received FDA 510(k) clearance on 2025-12-29 under 510(k) number K253343. 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 Celebrace Software?

Celebrace Software is a medical device that received FDA 510(k) clearance on 2025-12-29. The listed applicant is Celebrace. The 510(k) number is K253343.

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

Celebrace Software received FDA 510(k) clearance on 2025-12-29, under 510(k) number K253343.

Who is the listed applicant for Celebrace Software?

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

What is the FDA product code for Celebrace Software?

The FDA product code for Celebrace Software is PNN.

Related Devices (Code: PNN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260419LingOral Dental Design SystemHangzhou ChohoTech Co., Ltd.K253565SureSmile SoftwareDentsply Sirona, Inc.K252507SmileInspectorAmv Consulting, LLCK250198Laon OrthoLaon Medi, Inc.K241153Progressive Orthodontics AppProgressive Aligners, Inc.K233625RAYDENT SWRay Co., Ltd.

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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