1 device · 1 company · 2024
Product code QRY: Dental Navigation System
1 device under product code QRY, 2024, 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 Navigation System. 21 CFR 872.4120, Class II. Intended to provide real-time guidance on the orientation and location of the dental instrument relative to the patient's anatomy for general dentistry procedures. MAUDE held 9 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 |
|---|---|---|---|---|
| X-Guide Surgical Navigation SystemK232148 · 510(k) | X-Nav Technologies, LLC | Dental | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.