SIMPLANT® 54500394E2

GUDID 07392532181252

SIMPLANT Editor

Dentsply Implants NV

Panoramic/tomographic dental x-ray system application software

• Primary Device ID: 07392532181252
• NIH Device Record Key: 59345e5e-fa23-46bc-addb-920d9f96f708
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIMPLANT®
• Version Model Number: Version 2
• Catalog Number: 54500394E2
• 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: 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: +1(800)531-3481
• Email: implants-na-cs@dentsply.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07392532181252 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-30

On-Brand Devices [SIMPLANT®]

• 07392532181276: SIMPLANT Viewer
• 07392532181252: SIMPLANT Editor
• 07392532178030: SIMPLANT Pro
• 07392532177286: Immediate Smile Complete
• 07392532177279: Immediate Smile bridge