Zolid 767600

GUDID E4947676001

Amann Girrbach AG

Dental appliance fabrication material, ceramic

• Primary Device ID: E4947676001
• NIH Device Record Key: d23e98b8-1f24-486f-8ee2-d6ac183054e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zolid
• Version Model Number: Zolid Gen-X C3 98x14 F
• Catalog Number: 767600
• 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: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +43552362333200
• Email: austria@amanngirrbach.com
• Phone: +43552362333200
• Email: austria@amanngirrbach.com
• Phone: +43552362333200
• Email: austria@amanngirrbach.com
• Phone: +43552362333200
• Email: austria@amanngirrbach.com
• Phone: +43552362333200
• Email: austria@amanngirrbach.com
• Phone: +43552362333200
• Email: austria@amanngirrbach.com
• Phone: +43552362333200
• Email: austria@amanngirrbach.com
• Phone: +43552362333200
• Email: austria@amanngirrbach.com
• Phone: +43552362333200
• Email: austria@amanngirrbach.com
• Phone: +43552362333200
• Email: austria@amanngirrbach.com
• Phone: +43552362333200
• Email: austria@amanngirrbach.com
• Phone: +43552362333200
• Email: austria@amanngirrbach.com
• Phone: +43552362333200
• Email: austria@amanngirrbach.com
• Phone: +43552362333200
• Email: austria@amanngirrbach.com
• Phone: +43552362333200
• Email: austria@amanngirrbach.com
• Phone: +43552362333200
• Email: austria@amanngirrbach.com
• Phone: +43552362333200
• Email: austria@amanngirrbach.com
• Phone: +43552362333200
• Email: austria@amanngirrbach.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E4947676001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171876

FDA Product Code

• EIH: Powder, Porcelain

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: 2022-10-10
• Device Publish Date: 2022-09-30

On-Brand Devices [Zolid ]

• E4947669381: Zolid gen-x D2 98x20
• E4947669361: Zolid gen-x D2 98x16
• E4947669351: Zolid gen-x D2 98x14
• E4947669111: Zolid gen-x C2 98x20
• E4947669091: Zolid gen-x C2 98x16
• E4947669081: Zolid gen-x C2 98x14
• E4947669021: Zolid gen-x C1 98x20
• E4947669001: Zolid gen-x C1 98x16
• E4947668991: Zolid gen-x C1 98x14
• E4947668751: Zolid gen-x B2 98x20
• E4947668731: Zolid gen-x B2 98x16
• E4947668721: Zolid gen-x B2 98x14
• E4947668661: Zolid gen-x B1 98x20
• E4947668641: Zolid gen-x B1 98x16
• E4947668631: Zolid gen-x B1 98x14
• E4947668481: Zolid gen-x A3,5 98x20
• E4947668461: Zolid gen-x A3,5 98x16
• E4947668451: Zolid gen-x A3,5 98x14
• E4947668391: Zolid gen-x A3 98x20
• E4947668371: Zolid gen-x A3 98x16
• E4947668361: Zolid gen-x A3 98x14
• E4947668301: Zolid gen-x A2 98x20
• E4947668281: Zolid gen-x A2 98x16
• E4947668271: Zolid gen-x A2 98x14
• E4947668121: Zolid gen-x BL3 98x20
• E4947668101: Zolid gen-x BL3 98x16
• E4947668091: Zolid gen-x BL3 98x14
• E4947667471: Zolid gen-x D2 71x20
• E4947667451: Zolid gen-x D2 71x16
• E4947667441: Zolid gen-x D2 71x14
• E4947667201: Zolid gen-x C2 71x20
• E4947667181: Zolid gen-x C2 71x16
• E4947667171: Zolid gen-x C2 71x14
• E4947667111: Zolid gen-x C1 71x20
• E4947667091: Zolid gen-x C1 71x16
• E4947667081: Zolid gen-x C1 71x14
• E4947666841: Zolid gen-x B2 71x20
• E4947666821: Zolid gen-x B2 71x16
• E4947666811: Zolid gen-x B2 71x14
• E4947666751: Zolid gen-x B1 71x20
• E4947666731: Zolid gen-x B1 71x16
• E4947666721: Zolid gen-x B1 71x14
• E4947666571: Zolid gen-x A3,5 71x20
• E4947666551: Zolid gen-x A3,5 71x16
• E4947666541: Zolid gen-x A3,5 71x14
• E4947666481: Zolid gen-x A3 71x20
• E4947666461: Zolid gen-x A3 71x16
• E4947666451: Zolid gen-x A3 71x14
• E4947666391: Zolid gen-x A2 71x20
• E4947666371: Zolid gen-x A2 71x16