ZERAMEX® XT Implant Ø5.5x8mm WB (incl. Healing Cap XT17508

GUDID 07640161391840

Dental Implant

Dentalpoint AG

Dental implant system

• Primary Device ID: 07640161391840
• NIH Device Record Key: 768c3fb9-8681-4b6d-b072-5d45e2f876f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZERAMEX® XT Implant Ø5.5x8mm WB (incl. Healing Cap
• Version Model Number: XT17508
• Catalog Number: XT17508
• Company DUNS: 483229493
• Company Name: Dentalpoint AG
• Device Count: 1
• DM Exempt: true
• 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

Customer Support Contacts

• Phone: +41443883630
• Email: pascal.wettstein@zeramex.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, Keep out of sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640161391840 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180184

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: 2018-12-31
• Device Publish Date: 2018-11-30

Devices Manufactured by Dentalpoint AG

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• 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
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• 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