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FDA 510(k)

Overjet Caries Assist-Pediatric

K-Number: K233738 · 2024-03-04

ApplicantOverjet, Inc.
Decision Date2024-03-04
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Overjet Caries Assist-Pediatric is the device name listed in this FDA 510(k) record. The listed applicant is Overjet, Inc.. It received FDA 510(k) clearance on 2024-03-04 under 510(k) number K233738. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Overjet Caries Assist-Pediatric?

Overjet Caries Assist-Pediatric is a medical device that received FDA 510(k) clearance on 2024-03-04. The listed applicant is Overjet, Inc.. The 510(k) number is K233738.

When did Overjet Caries Assist-Pediatric receive FDA 510(k) clearance?

Overjet Caries Assist-Pediatric received FDA 510(k) clearance on 2024-03-04, under 510(k) number K233738.

Who is the listed applicant for Overjet Caries Assist-Pediatric?

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 Caries Assist-Pediatric?

The FDA product code for Overjet Caries Assist-Pediatric is MYN.

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 SystemK251514Overjet CBCT AssistK241681Overjet Image Enhancement AssistK241684Overjet Charting AssistK233590Overjet Charting Assist

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Related Devices (Code: MYN)

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 AssistOverjet, Inc.K260851Better Diagnostics Dental Assist (BDDA) Version 1.0Better Diagnostics AI Corp.K252953Velmeni for Dentists (V4D) Endo-PerioVelmeni, Inc.K251934qXR-DetectQure.Ai TechnologiesK252934DiagnocatDGNCT, LLCK253009DS Core DetectDentsply Sirona, 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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