CS 8100SC Access 5319421

GUDID 60192155319426

CS 8100SC ACCESS

CARESTREAM DENTAL LLC

Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital

• Primary Device ID: 60192155319426
• NIH Device Record Key: b98663bd-93cf-4346-b462-e4a270541637
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CS 8100SC Access
• Version Model Number: CS 8100SC Access
• Catalog Number: 5319421
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	60192155319426 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151087

FDA Product Code

• MUH: System,x-ray,extraoral source,digital

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-06-07
• Device Publish Date: 2018-01-15

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