Cleared Traditional

Celebrace Software

K253343 · Celebrace · Dental

Dec 2025

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K253343 is an FDA 510(k) clearance for the Celebrace Software, a Orthodontic Software (Class II — Special Controls, product code PNN), submitted by Celebrace (Colleyville, US). The FDA issued a Cleared decision on December 29, 2025, 90 days after receiving the submission on September 30, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number	K253343 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2025
Decision Date	December 29, 2025
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	PNN — Orthodontic Software
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.5470
Definition	The Device Is Software That Is To Be Used For The Diagnosis And Treatment Planning Of Orthodontic Patients And Conditions. It May Include Orthodontic Output Devices Used For The Treatment Of Orthodontics. The Device Is Intended For Prescription Use Only.