Ceramill® Zolid 760340

GUDID E4947603401

Amann Girrbach AG

Dental appliance fabrication material, ceramic

• Primary Device ID: E4947603401
• NIH Device Record Key: 65c49f2b-1137-413f-838c-eaceef4d956b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ceramill® Zolid
• Version Model Number: Zolid preshade 1 71 XS (12mm)
• Catalog Number: 760340
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: true
• 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	E4947603401 [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® Zolid]

• E4947615891: Zolid fx PS D light 98x20 N
• E4947615871: Zolid fx PS D light 98x16 N
• E4947615861: Zolid fx PS D light 98x14 N
• E4947615791: Zolid fx PS C light 98x20 N
• E4947615771: Zolid fx PS C light 98x16 N
• E4947615761: Zolid fx PS C light 98x14 N
• E4947615691: Zolid fx PS B light 98x20 N
• E4947615671: Zolid fx PS B light 98x16 N
• E4947615661: Zolid fx PS B light 98x14 N
• E4947615641: Zolid fx PS A medium 98x20 N
• E4947615621: Zolid fx PS A medium 98x16 N
• E4947615611: Zolid fx PS A medium 98x14 N
• E4947615591: Zolid fx PS A light 98x20 N
• E4947615571: Zolid fx PS A light 98x16 N
• E4947615561: Zolid fx PS A light 98x14 N
• E4947615541: Zolid fx PS bleach 98x20 N
• E4947615521: Zolid fx PS bleach 98x16 N
• E4947615511: Zolid fx PS bleach 98x14 N
• E4947615391: Zolid fx PS D light 71 L (20mm)
• E4947615371: Zolid fx PS D light 71 (16mm)
• E4947615361: Zolid fx PS D light 71 S (14mm)
• E4947615291: Zolid fx PS C light 71 L (20mm)
• E4947615271: Zolid fx PS C light 71 (16mm)
• E4947615261: Zolid fx PS C light 71 S (14mm)
• E4947615191: Zolid fx PS B light 71 L (20mm)
• E4947615171: Zolid fx PS B light 71 (16mm)
• E4947615161: Zolid fx PS B light 71 S (14mm)
• E4947615141: Zolid fx PS A medium 71 L (20mm)
• E4947615121: Zolid fx PS A medium 71 (16mm)
• E4947615111: Zolid fx PS A medium 71 S 14mm
• E4947615091: Zolid fx PS A light 71 L (20mm)
• E4947615071: Zolid fx PS A light 71 (16mm)
• E4947615061: Zolid fx PS A light 71 S (14mm)
• E4947615041: Zolid fx PS bleach 71 L (20mm)
• E4947615021: Zolid fx PS bleach 71 (16mm)
• E4947615011: Zolid fx PS bleach 71 S (14mm)
• E494760348STM1: Zolid-HT preshade 3 20mm
• E4947603481: Zolid preshade 3 71 L (20mm)
• E494760347STM1: Zolid-HT preshade 3 16mm
• E4947603471: Zolid preshade 3 71 (16mm)
• E494760346STM1: Zolid-HT preshade 3 12mm
• E4947603461: Zolid preshade 3 71 XS (12mm)
• E494760345STM1: Zolid-HT preshade 2 20mm
• E4947603451: Zolid preshade 2 71 L (20mm)
• E494760344STM1: Zolid-HT preshade 2 16mm
• E4947603441: Zolid preshade 2 71 (16mm)
• E494760343STM1: Zolid-HT preshade 2 12mm
• E4947603431: Zolid preshade 2 71 XS (12mm)
• E494760342STM1: Zolid-HT preshade 1 20mm
• E4947603421: Zolid preshade 1 71 L (20mm)