inforMED
SBCClass II

Dental Image Analyzer

Dental · 21 CFR 872.1770

A dental image analyzer is a prescription home use device that uses software intended to collect and analyze patient-specific, optical camera-based, intraoral images. The analyses are provided to dental health care professionals as an aid to diagnosis of oral health conditions and/or to monitor treatment progress.

MDR events0All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances1All time

Recent MDR events

0 adverse event reports on file

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No MDR events on file for this product code.

Event type breakdown

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Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

2 firms currently registered for this product code

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510(k) clearances

1 clearances for this product code

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