Primescan 2 6802040

GUDID E27668020400

Primescan 2

SIRONA Dental Systems GmbH

Intraoral optical scanning system

• Primary Device ID: E27668020400
• NIH Device Record Key: 470a0cd9-d597-4315-bafd-57f16116274c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Primescan 2
• Version Model Number: 6802040
• Catalog Number: 6802040
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E27668020400 [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: 2025-05-26
• Device Publish Date: 2025-05-16

On-Brand Devices [Primescan 2]

• E27668310150: 6831015
• E27668127750: 6818699
• E27668356100: Primescan 2 Spare
• E27668020400: Primescan 2
• E2766802040: Primescan 2