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FDA 510(k)

Overjet CBCT Assist

K-Number: K251514 · 2025-12-05

ApplicantOverjet, Inc.
Decision Date2025-12-05
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Overjet CBCT Assist is the device name listed in this FDA 510(k) record. The listed applicant is Overjet, Inc.. It received FDA 510(k) clearance on 2025-12-05 under 510(k) number K251514. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Overjet CBCT Assist?

Overjet CBCT Assist is a medical device that received FDA 510(k) clearance on 2025-12-05. The listed applicant is Overjet, Inc.. The 510(k) number is K251514.

When did Overjet CBCT Assist receive FDA 510(k) clearance?

Overjet CBCT Assist received FDA 510(k) clearance on 2025-12-05, under 510(k) number K251514.

Who is the listed applicant for Overjet CBCT Assist?

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

What is the FDA product code for Overjet CBCT Assist?

The FDA product code for Overjet CBCT Assist is QIH.

Other records listing Overjet, Inc. as applicant

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.

K261059Overjet Multi-Image Caries and Charting AssistK253930Overjet Iris Intelligent Imaging SystemK241681Overjet Image Enhancement AssistK241684Overjet Charting AssistK233738Overjet Caries Assist-PediatricK233590Overjet Charting Assist

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Related Devices (Code: QIH)

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.

K253794Prostate CoreLucida Medical, Ltd.K252571mdprostateMediaire GmbHK253902RealGUIDE3DIEMME SRLK253835AffinityHermes Medical Solutions ABK260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, Inc.

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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