ZOLID_SHT 761777-STM

GUDID E494761777STM1

Amann Girrbach AG

Dental appliance fabrication material, ceramic

• Primary Device ID: E494761777STM1
• NIH Device Record Key: 718f5b21-3c0f-4c1f-92f8-197e2f8fa2f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZOLID_SHT
• Version Model Number: ZOLID-SHT multilayer 0/A1 98x16mm
• Catalog Number: 761777-STM
• Company DUNS: 300708950
• Company Name: Amann Girrbach 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +43552362333105
• Email: austria@amanngirrbach.com
• Phone: +43552362333105
• Email: austria@amanngirrbach.com
• Phone: +43552362333105
• Email: austria@amanngirrbach.com
• Phone: +43552362333105
• Email: austria@amanngirrbach.com
• Phone: +43552362333105
• Email: austria@amanngirrbach.com
• Phone: +43552362333105
• Email: austria@amanngirrbach.com
• Phone: +43552362333105
• Email: austria@amanngirrbach.com
• Phone: +43552362333105
• Email: austria@amanngirrbach.com
• Phone: +43552362333105
• Email: austria@amanngirrbach.com
• Phone: +43552362333105
• Email: austria@amanngirrbach.com
• Phone: +43552362333105
• Email: austria@amanngirrbach.com
• Phone: +43552362333105
• Email: austria@amanngirrbach.com
• Phone: +43552362333105
• Email: austria@amanngirrbach.com
• Phone: +43552362333105
• Email: austria@amanngirrbach.com
• Phone: +43552362333105
• Email: austria@amanngirrbach.com
• Phone: +43552362333105
• Email: austria@amanngirrbach.com
• Phone: +43552362333105
• Email: austria@amanngirrbach.com
• Phone: +43552362333105
• Email: austria@amanngirrbach.com
• Phone: +43552362333105
• Email: austria@amanngirrbach.com
• Phone: +43552362333105
• Email: austria@amanngirrbach.com
• Phone: +43552362333105
• Email: austria@amanngirrbach.com
• Phone: +43552362333105
• Email: austria@amanngirrbach.com
• Phone: +43552362333105
• Email: austria@amanngirrbach.com
• Phone: +43552362333105
• Email: austria@amanngirrbach.com
• Phone: +43552362333105
• Email: austria@amanngirrbach.com
• Phone: +43552362333105
• Email: austria@amanngirrbach.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E494761777STM1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152383

FDA Product Code

• EIH: Powder, Porcelain

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-24
• Device Publish Date: 2017-11-17

Devices Manufactured by Amann Girrbach AG

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• E4947682281 - Zolid: 2023-03-17
• E4947682291 - Zolid: 2023-03-17
• E4947682301 - Zolid: 2023-03-17
• E4947682311 - Zolid: 2023-03-17
• E4947682321 - Zolid: 2023-03-17
• E4947682331 - Zolid: 2023-03-17
• E4947682371 - Zolid: 2023-03-17