Trophy 3D Imaging 5319553

GUDID 60192155319556

TROPHY 3D IMAGING

CARESTREAM DENTAL LLC

General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software

• Primary Device ID: 60192155319556
• NIH Device Record Key: 6d0495b1-be10-499c-a1ea-bfaf47c0d6fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trophy 3D Imaging
• Version Model Number: Trophy 3D Imaging
• Catalog Number: 5319553
• Company DUNS: 019796106
• Company Name: CARESTREAM DENTAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	60192155319556 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151837

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-25
• Device Publish Date: 2020-02-17

Devices Manufactured by CARESTREAM DENTAL LLC

• 60192155945076 - RIOSensor+: 2024-01-25 RIOSensor+ Size 1
• 60192155945083 - RIOSENSOR+: 2024-01-25 RIOSENSOR+ SIZE 2
• 60192155944864 - CS 8200 3D Access: 2023-12-20 CS 8200 3D ACCESS
• 60192155944833 - DENTRA III: 2023-06-12 DENTRA III SIZE 1
• 60192155944840 - DENTRA III: 2023-06-12 DENTRA III SIZE 2
• 60192155944543 - Swissmeda powered by Carestream Dental: 2022-10-31 Swissmeda powered by Carestream Dental
• 60192155943720 - CS 3800 Wired: 2022-02-21 CS 3800 3D I/O SCANNER WIRED
• 60192155944482 - CS Model+: 2021-11-15 LICENCE CS MODEL+ V5 ALIGNER CAPABILITY