1 device · 1 company · 2026
Product code SHQ: Dental Image Analyzer, In-Office
1 device under product code SHQ, 2026, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Dental Image Analyzer, In-Office. 21 CFR 872.1770, Class II. A dental image analyzer for in-office use is a prescription device that uses software intended to collect and analyze patient-specific, optical camera-based, intraoral images to be used by dental health care professionals as an aid to diagnosis of oral health conditions. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| TRIOS DxK260082 · 510(k) | 3Shape TRIOS A/S | Dental | database entry |
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