ZERAMEX® XT Implant Ø3.5x10mm SB (incl. Healing Cap)

GUDID 07640161394018

Dental Implant

Dentalpoint AG

Dental implant system

• Primary Device ID: 07640161394018
• NIH Device Record Key: c33b152c-344e-400c-8a48-fa6df653dbd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZERAMEX® XT Implant Ø3.5x10mm SB (incl. Healing Cap)
• Version Model Number: XT15510
• Company DUNS: 483229493
• Company Name: Dentalpoint AG
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640161394018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163043

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-21
• Device Publish Date: 2020-10-13

Devices Manufactured by Dentalpoint AG

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• 07640161393776 - ZERAMEX®XT Rescue-Shell XT WIDE: 2024-05-15 ZERAMEX®XT Rescue-Shell XT WIDE
• 07640161395077 - ZERAMEX®XT Rescue-Shell XT SMALL: 2024-05-15 ZERAMEX®XT Rescue-Shell XT SMALL
• 07640161396401 - CERALOG PL Implant, Ø 3.8 L 9: 2024-05-07 Dental Implant
• 07640161396432 - CERALOG PL Implant, Ø 3.8 L 11: 2024-05-07 Dental Implant
• 07640161396449 - CERALOG PL Implant, Ø 3.8 L 13: 2024-05-07 Dental Implant
• 07640161396456 - CERALOG PL Implant, Ø 4.3 L 9: 2024-05-07 Dental Implant
• 07640161396463 - CERALOG PL Implant,Ø 4.3 L 11: 2024-05-07 Dental Implant