Simplant 54500277O18

GUDID 07392532191237

Simplant OneShot

DENTSPLY IH, INC.

Panoramic/tomographic dental x-ray system application software

• Primary Device ID: 07392532191237
• NIH Device Record Key: 4035d386-a538-4976-a1a1-b88cde6551f8
• Commercial Distribution Discontinuation: 2019-02-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Simplant
• Version Model Number: Version 18
• Catalog Number: 54500277O18
• Company DUNS: 847337201
• Company Name: DENTSPLY IH, INC.
• 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	07392532191237 [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

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