Home GUDID 00860005586301 Overjet Dental Assist
Primary DI 00860005586301
Brand Overjet Dental Assist
Company Overjet, Inc.
Model v1
Published 2024-11-12
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 00860005586301 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 00860005586301 00860005586301 860005586301 0860005586301
GMDN Terms# Term, Definition table Term Definition Dental clinical assessment support radiology software A software program intended to display, analyse/process, and possibly acquire images of the teeth/gums, and typically surrounding region, to support a healthcare provider with clinical assessment (e.g., diagnosis, triage) of a dental condition. The images are typically acquired via x-ray [e.g., cone beam computed tomography (CBCT)] or by an intraoral camera. It is not dedicated to surgical planning or navigation, and does not incorporate adaptive/dynamic machine learning (ML) models.
Regulatory Flags# DUNS number 116916753 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07350092810722 Sectra Orthopedic Package Sectra AB LLZ 2026-09-06 00754016387128 ANDI Imeka Solutions Inc LLZ 2026-05-14 00198953059173 ViewPoint GE Healthcare GmbH LLZ 2026-02-27 00817886020677 Joints MEDSTRAT, INC. LLZ 2026-02-16 00817886020660 Joints MEDSTRAT, INC. LLZ 2025-08-09 00817886020653 Joints MEDSTRAT, INC. LLZ 2025-06-27 00817886020646 Joints MEDSTRAT, INC. LLZ 2025-04-30 00817886020639 Joints MEDSTRAT, INC. LLZ 2025-03-07 00198715251623 BrainSpec Core™ Software BrainSpec Inc. LLZ 2025-02-10 00817886020622 Joints MEDSTRAT, INC. LLZ 2025-02-03 00670082000610 Modus Plan Synaptive Medical Inc LLZ 2025-01-17 00817886020615 Joints MEDSTRAT, INC. LLZ 2024-12-09 00817886020608 Joints MEDSTRAT, INC. LLZ 2024-11-01 00817886020592 Joints MEDSTRAT, INC. LLZ 2024-08-31 00195278753472 ViewPoint GE Healthcare GmbH LLZ 2024-07-15 00817886020585 Joints MEDSTRAT, INC. LLZ 2024-06-08 00817886020578 Joints MEDSTRAT, INC. LLZ 2024-04-12 00817886020561 Joints MEDSTRAT, INC. LLZ 2024-02-10 00817886020554 Joints MEDSTRAT, INC. LLZ 2023-11-13 00350227000520 Eaglesoft PATTERSON TECHNOLOGY CENTER LLZ 2023-10-25 00754016387111 ANDI Imeka Solutions Inc LLZ 2023-09-01 00817886020516 Joints MEDSTRAT, INC. LLZ 2023-05-29 00817886020509 Joints MEDSTRAT, INC. LLZ 2023-04-03 00817886020493 Joints MEDSTRAT, INC. LLZ 2023-03-06 00195278517340 ViewPoint GE Healthcare GmbH LLZ 2023-02-15 00817886020486 Joints MEDSTRAT, INC. LLZ 2023-01-20 00670082000511 Modus Plan Synaptive Medical Inc LLZ 2022-12-13 00817886020479 Joints MEDSTRAT, INC. LLZ 2022-10-29 00817886020462 Joints MEDSTRAT, INC. LLZ 2022-09-05 00817886020455 Joints MEDSTRAT, INC. LLZ 2022-08-01