Primescan 2 Cart 6800457

GUDID E27668004570

Primescan 2 Cart

SIRONA Dental Systems GmbH

Intraoral optical scanning system

• Primary Device ID: E27668004570
• NIH Device Record Key: 5ed1fa60-8625-441e-a6ae-c7ecfccd16a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Primescan 2 Cart
• Version Model Number: 6800457
• Catalog Number: 6800457
• Company DUNS: 340306351
• Company Name: SIRONA Dental Systems GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Customer Support Contacts

• Phone: +4962511670
• Email: contact@dentsplysirona.com
• Phone: +4962511670
• Email: contact@dentsplysirona.com
• Phone: +4962511670
• Email: contact@dentsplysirona.com
• Phone: +4962511670
• Email: contact@dentsplysirona.com
• Phone: +4962511670
• Email: contact@dentsplysirona.com
• Phone: +4962511670
• Email: contact@dentsplysirona.com
• Phone: +4962511670
• Email: contact@dentsplysirona.com
• Phone: +4962511670
• Email: contact@dentsplysirona.com
• Phone: +4962511670
• Email: contact@dentsplysirona.com
• Phone: +4962511670
• Email: contact@dentsplysirona.com
• Phone: +4962511670
• Email: contact@dentsplysirona.com
• Phone: +4962511670
• Email: contact@dentsplysirona.com
• Phone: +4962511670
• Email: contact@dentsplysirona.com
• Phone: +4962511670
• Email: contact@dentsplysirona.com
• Phone: +4962511670
• Email: contact@dentsplysirona.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E27668004570 [Primary]

FDA Product Code

• NOF: System, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations

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: 2025-03-13
• Device Publish Date: 2025-03-05

Devices Manufactured by SIRONA Dental Systems GmbH

• E27665716860 - SiroLaser: 2025-09-11 single-use tips pack 250
• E27662122080 - Motor BL implant: 2025-08-28 Motor BL implant
• E27668534800 - CAD/CAM Software: 2025-08-27 CEREC SW 5.2 Full version, Primary, EDU
• E2766802040 - Primescan 2: 2025-05-26 Primescan 2
• E27668020400 - Primescan 2: 2025-05-26 Primescan 2
• E27668053650 - Primescan 2 Multiuse Sleeve: 2025-05-14 Primescan 2 Multiuse Sleeve
• E27668325750 - TiBase: 2025-05-14 TiBase AT EV 3.0 GH2 S
• E27668325830 - TiBase: 2025-05-14 TiBase AT EV 3.6 GH2 S