Ceramill® ZI 760216

GUDID E4947602161

Amann Girrbach AG

Dental appliance fabrication material, ceramic

• Primary Device ID: E4947602161
• NIH Device Record Key: f2c1c70c-d72d-425f-b406-2978c82e8caa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ceramill® ZI
• Version Model Number: ZI CAM 98x18 (8 pcs.)
• Catalog Number: 760216
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E4947602161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063511

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: 2016-06-30

On-Brand Devices [Ceramill® ZI]

• E4947602391: ZI CAM 98x20 R (1pcs.)
• E4947602331: ZI CAM 98x14 R (1 pcs.)
• E494760229STM1: ZI 98x25mm
• E4947602291: ZI CAM 98x25 N (1pcs.)
• E494760227STM1: ZI 98x20mm
• E4947602271: ZI CAM 98x20 N (1pcs.)
• E494760225STM1: ZI 98x18mm
• E4947602251: ZI CAM 98x18 N (1pcs.)
• E494760223STM1: ZI 98x16mm
• E4947602231: ZI CAM 98x16 N (1pcs.)
• E4947602221: ZI CAM 98x14 N (8 pcs.)
• E494760221STM1: ZI 98x14mm
• E4947602211: ZI CAM 98x14 N (1pcs.)
• E4947602191: ZI CAM 98x25 (1pcs.)
• E4947602181: ZI CAM 98x20 (8 pcs.)
• E4947602171: ZI CAM 98x20 (1pcs.)
• E4947602161: ZI CAM 98x18 (8 pcs.)
• E4947602141: ZI CAM 98x16 (8pcs.)
• E4947602121: ZI CAM 98x14 (8pcs.)
• E4947602111: ZI CAM 98x14 (1pcs.)
• E4947602101: ZI CAM 98x10 (8pcs.)
• E4947602091: ZI CAM 98x10 (1pcs.)
• E4947601871: ZI 77XL (25mm) für Multi-x
• E4947601841: ZI 71L (20mm)
• E4947601831: ZI 77XL (25mm)
• E4947601811: ZI 77L (20mm)
• E494760176STM1: ZI 18mm
• E4947601761: ZI 71 M (18mm)
• E494760175STM1: ZI 25mm
• E4947601751: ZI 71XL (25mm)
• E494760174STM1: ZI 16mm
• E4947601741: ZI 71 (16mm)
• E494760173STM1: ZI 14mm
• E4947601731: ZI 71 S (14mm)
• E494760172STM1: ZI 12mm
• E4947601721: ZI 71 XS (12mm)
• E4947601433: ZI 51L 3pcs.
• E4947601166: ZI 31 6pcs.
• E49476011012: Ceramill ZI TC L 12Stk.
• E49476010212: Ceramill ZI Preforms L 12Rohl.
• E49476010112: Ceramill ZI Preforms 12 Rohl.
• E4947660184STM1: ZI 20mm
• E494760184STM1: ZI 20mm