SIMPLANT 68017305

GUDID 07392532279836

C/Guide Sleeve 3.4 XND PrimeTaper/AstraTech Implant EV

Dentsply Implants Manufacturing GmbH

Dental implantation drilling template guide-sleeve

• Primary Device ID: 07392532279836
• NIH Device Record Key: 3e8ce5aa-6ca5-4f77-82c4-6e080318101c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIMPLANT
• Version Model Number: 68017305
• Catalog Number: 68017305
• Company DUNS: 344038836
• Company Name: Dentsply Implants Manufacturing 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: true
• Lot Batch: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07392532279836 [Primary]

FDA Product Code

• NDP: Accessories, implant, dental, endosseous

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: 2024-10-04
• Device Publish Date: 2024-09-26

Devices Manufactured by Dentsply Implants Manufacturing GmbH

• 07392532212130 - XiVE®: 2024-11-21 XiVE® TG plus Implant D3.4/L11
• 07392532212147 - XiVE®: 2024-11-21 XiVE® TG plus Implant D3.4/L13
• 07392532212154 - XiVE®: 2024-11-21 XiVE® TG plus Implant D3.4/L15
• 07392532212178 - XiVE®: 2024-11-21 XiVE® TG plus Implant D3.8/L9.5
• 07392532212192 - XiVE®: 2024-11-21 XiVE® TG plus Implant D3.8/L13
• 07392532212222 - XiVE®: 2024-11-21 XiVE® TG plus Implant D4.5/L9.5
• 07392532223167 - XiVE®: 2024-11-21 XiVE® TG Lab Set Soldering Analog Bridge
• 07392532223174 - XiVE®: 2024-11-21 XiVE® TG Lab Set Soldering Analog Bar