ZIRKONZAHN.Implant-Planner

GUDID D800SY1600

Rights of use Zirkonzahn.Implant-Planner The conclusion of the Zirkonzahn.Implant-Planner service contract is obligatory for the duration of 12 months! Rights of use for Helpdesk customer support and automatic software updates for Zirkonzahn.Implant-Planner

ZIRKONZAHN SRL

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• Primary Device ID: D800SY1600
• NIH Device Record Key: 185bc283-94c0-4980-a45d-b547444f3402
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZIRKONZAHN.Implant-Planner
• Version Model Number: SY1600
• Company DUNS: 564251911
• Company Name: ZIRKONZAHN SRL
• 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: 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: +390474066660
• Email: info@zirkonzahn.com
• Phone: +390474066660
• Email: info@zirkonzahn.com
• Phone: +390474066660
• Email: info@zirkonzahn.com
• Phone: +390474066660
• Email: info@zirkonzahn.com
• Phone: +390474066660
• Email: info@zirkonzahn.com
• Phone: +390474066660
• Email: info@zirkonzahn.com
• Phone: +390474066660
• Email: info@zirkonzahn.com
• Phone: +390474066660
• Email: info@zirkonzahn.com
• Phone: +390474066660
• Email: info@zirkonzahn.com
• Phone: +390474066660
• Email: info@zirkonzahn.com
• Phone: +390474066660
• Email: info@zirkonzahn.com
• Phone: +390474066660
• Email: info@zirkonzahn.com
• Phone: +390474066660
• Email: info@zirkonzahn.com
• Phone: +390474066660
• Email: info@zirkonzahn.com
• Phone: +390474066660
• Email: info@zirkonzahn.com
• Phone: +390474066660
• Email: info@zirkonzahn.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D800SY1600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203765

FDA Product Code

• LLZ: System, image processing, radiological

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: 2021-09-30
• Device Publish Date: 2021-09-22

Devices Manufactured by ZIRKONZAHN SRL

• D800CPAD01010 - Polibond 30 ml: 2023-10-09 Content: Liquid for bonding Zirkonzahn Abro Basic Mono, Abro Basic Multistratum and Denture Gingiva Basic Mono resins as well as
• D800DSAD10610PIN0 - Denture Gingiva Basic Mono Pink 106H10: 2023-10-09 Content: 1 piece Height: 10 mm Gingiva-coloured resin with improved material properties in terms of high flexural strength and f
• D800DSAD10611PIN0 - Denture Gingiva Basic Mono Pink 106H11: 2023-10-09 Content: 1 piece Height: 11 mm Gingiva-coloured resin with improved material properties in terms of high flexural strength and f
• D800DSAD10612PIN0 - Denture Gingiva Basic Mono Pink 106H12: 2023-10-09 Content: 1 piece Height: 12 mm Gingiva-coloured resin with improved material properties in terms of high flexural strength and f
• D800DSAD10613PIN0 - Denture Gingiva Basic Mono Pink 106H13: 2023-10-09 Content: 1 piece Height: 13 mm Gingiva-coloured resin with improved material properties in terms of high flexural strength and f
• D800DSAD10614PIN0 - Denture Gingiva Basic Mono Pink 106H14: 2023-10-09 Content: 1 piece Height: 14 mm Gingiva-coloured resin with improved material properties in terms of high flexural strength and f
• D800DSAD10615PIN0 - Denture Gingiva Basic Mono Pink 106H15: 2023-10-09 Content: 1 piece Height: 15 mm Gingiva-coloured resin with improved material properties in terms of high flexural strength and f
• D800DSAD10616PIN0 - Denture Gingiva Basic Mono Pink 106H16: 2023-10-09 Content: 1 piece Height: 16 mm Gingiva-coloured resin with improved material properties in terms of high flexural strength and f