Nical Smart Micro NSM1001AA

GUDID 08056600521331

NICAL SPA

Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner

• Primary Device ID: 08056600521331
• NIH Device Record Key: 80b2c25a-89f7-440c-97a3-731c4004d053
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nical Smart Micro
• Version Model Number: NPR System
• Catalog Number: NSM1001AA
• Company DUNS: 435743877
• Company Name: NICAL SPA
• 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: true
• Manufacturing Date: true
• 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	08056600521331 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143703

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-06
• Device Publish Date: 2023-09-28

On-Brand Devices [Nical Smart Micro]

• 08056600521355: NPR System
• 08056600521348: NPR System
• 08056600521331: NPR System
• 08056600520037: NPR System
• 08056600520020: NPR System
• 08056600520013: NPR System
• 08056600520006: NPR System