Home GUDID 00860012615308 Denti.AI Auto-Chart
Primary DI 00860012615308
Brand Denti.AI Auto-Chart
Company Denti.AI Technology Inc
Model 21.06.22
Device description Denti.AI Auto-Chart (MIMPS): AI-assisted dental charting system detecting teeth, numbering, and restorations (implants, crowns, fillings) from 2D X-Ray images
Published 2026-06-24
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name LLZ System, Image Processing, Radiological
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LLZ System, Image Processing, Radiological Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860012615308 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860012615308 00860012615308 860012615308 0860012615308
GMDN Terms# Term, Definition table Term Definition General-purpose dental x-ray system application software An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a general-purpose dental x-ray system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some application software routines or groups of routines (packages) must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.
Regulatory Flags# DUNS number 204120372 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00860012615315 Denti.AI Detect 1.3 2026-06-24
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