Home GUDID 00860012615315 Denti.AI Detect
Primary DI 00860012615315
Brand Denti.AI Detect
Company Denti.AI Technology Inc
Model 1.3
Device description Denti.AI Detect is a prescription-use CADe device for dentists that detects caries and periapical radiolucency in teeth and aids in measuring medial and distal bone levels per tooth.
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 00860012615315 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 00860012615315 00860012615315 860012615315 0860012615315
GMDN Terms# Term, Definition table Term Definition Radiology DICOM image processing application software A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).
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 00860012615308 Denti.AI Auto-Chart 21.06.22 2026-06-24
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