Simplant 54500277P18

GUDID 07392532191251

Simplant Pro

Dentsply Implants NV

Panoramic/tomographic dental x-ray system application software

• Primary Device ID: 07392532191251
• NIH Device Record Key: 53f03760-5662-457e-967d-dfc11cfd68dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simplant
• Version Model Number: Version 18
• Catalog Number: 54500277P18
• Company DUNS: 764142159
• Company Name: Dentsply Implants NV
• 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: false
• Manufacturing Date: true
• 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: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.

Device Identifiers

Device Issuing Agency	Device ID
GS1	07392532191251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172239

FDA Product Code

• LLZ: System, image processing, radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-06
• Device Publish Date: 2018-05-01

On-Brand Devices [Simplant]

• 07392532209413: Case Viewer
• 07392532208423: Simplant Editor
• 07392532205583: Case Viewer
• 07392532204814: Simplant Editor
• 07392532191251: Simplant Pro
• 07392532191220: Simplant View
• 07392532208416: Simplant View
• 07392532206269: Simplant Pro