BL-OST-H BL-OST-H

GUDID 07640166764700

Titanium basal screw, including single-use screwdriver

Z-Systems AG

Dental prosthesis/implant abutment screw

• Primary Device ID: 07640166764700
• NIH Device Record Key: 435c50a9-2e46-41be-b732-2e73d4a131c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BL-OST-H
• Version Model Number: BL-OST-H
• Catalog Number: BL-OST-H
• Company DUNS: 483189556
• Company Name: Z-Systems 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: 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: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640166764700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190243

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

[07640166764700]

Moist Heat or Steam Sterilization

[07640166764700]

Moist Heat or Steam Sterilization

[07640166764700]

Moist Heat or Steam Sterilization

[07640166764700]

Moist Heat or Steam Sterilization

[07640166764700]

Moist Heat or Steam Sterilization

[07640166764700]

Moist Heat or Steam Sterilization

[07640166764700]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-15
• Device Publish Date: 2024-04-05

Devices Manufactured by Z-Systems AG

• 07640166769491 - Z5m: 2024-04-19 Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-36-10
• 07640166760870 - BL-OSC-H: 2024-04-15 Ceramic Basal Screw, incl. single-use screwdriver
• 07640166764700 - BL-OST-H: 2024-04-15Titanium basal screw, including single-use screwdriver
• 07640166764700 - BL-OST-H: 2024-04-15 Titanium basal screw, including single-use screwdriver
• 07640166760863 - BL-OST: 2024-04-12 Basal Screw
• 07640166761747 - Z5_m_c_mt leer: 2024-04-12 Surgical Tray Z5_m_c_mt_empty
• 07640166761754 - Z5_m_c_mt Inlay: 2024-04-12 Surgical Inlay Z5_m_c_mt
• 07640166761761 - Z5_Tray_Box: 2024-04-12 Surgical Box
• 07640166761778 - Z5_m_c_mt Tray FULL: 2024-04-12 Surgical Tray Z5_m_c_mt full