ZOLID-SHT 1

GUDID E494761769STM1

Amann Girrbach AG

Dental appliance fabrication material, ceramic

• Primary Device ID: E494761769STM1
• NIH Device Record Key: e4750b32-a22d-4033-a66b-0daeabc055da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZOLID-SHT
• Version Model Number: ZOLID-SHT multilayer D3/D4 14mm
• Catalog Number: 1
• 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	E494761769STM1 [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

On-Brand Devices [ZOLID-SHT]

• E494761589STM1: ZOLID-SHT preshade D light 98x20mm
• E494761587STM1: ZOLID-SHT preshade D light 98x16mm
• E494761586STM1: ZOLID-SHT preshade D light 98x14mm
• E494761579STM1: ZOLID-SHT preshade C light 98x20mm
• E494761577STM1: ZOLID-SHT preshade C light 98x16mm
• E494761576STM1: ZOLID-SHT preshade C light 98x14mm
• E494761569STM1: ZOLID-SHT preshade B light 98x20mm
• E494761567STM1: ZOLID-SHT preshade B light 98x16mm
• E494761566STM1: ZOLID-SHT preshade B light 98x14mm
• E494761564STM1: ZOLID-SHT preshade A medium 98x20mm
• E494761562STM1: ZOLID-SHT preshade A medium 98x16mm
• E494761561STM1: ZOLID-SHT preshade A medium 98x14mm
• E494761559STM1: ZOLID-SHT preshade A light 98x20mm
• E494761557STM1: ZOLID-SHT preshade A light 98x16mm
• E494761556STM1: ZOLID-SHT preshade A light 98x14mm
• E494761554STM1: ZOLID-SHT preshade bleach 98x20mm
• E494761552STM1: ZOLID-SHT preshade bleach 98x16mm
• E494761551STM1: ZOLID-SHT preshade bleach 98x14
• E494761539STM1: ZOLID-SHT preshade D light 20mm
• E494761537STM1: ZOLID-SHT preshade D light 16mm
• E494761536STM1: ZOLID-SHT preshade D light 14mm
• E494761529STM1: ZOLID-SHT preshade C light 20mm
• E494761527STM1: ZOLID-SHT preshade C light 16mm
• E494761526STM1: ZOLID-SHT preshade C light 14mm
• E494761519STM1: ZOLID-SHT preshade B light 20mm
• E494761517STM1: ZOLID-SHT preshade B light 16mm
• E494761516STM1: ZOLID-SHT preshade B light 14mm
• E494761514STM1: ZOLID-SHT preshade A medium 20mm
• E494761512STM1: ZOLID-SHT preshade A medium 16mm
• E494761511STM1: ZOLID-SHT preshade A medium 14mm
• E494761509STM1: ZOLID-SHT preshade A light 20mm
• E494761507STM1: ZOLID-SHT preshade A light 16mm
• E494761506STM1: ZOLID-SHT preshade A light 14mm
• E494761504STM1: ZOLID-SHT preshade bleach 20mm
• E494761502STM1: ZOLID-SHT preshade bleach 16mm
• E494761501STM1: ZOLID-SHT preshade bleach 14mm
• E494761814STM1: ZOLID-SHT multilayer D37D4 98x20mm
• E494761813STM1: ZOLID-SHT multilayer D3/D4 98x16mm
• E494761812STM1: ZOLID-SHT multilayer D3/D4 98x14mm
• E494761810STM1: ZOLID-SHT multilayer D2/D3 98x20mm
• E494761809STM1: ZOLID-SHT multilayer D2/D3 98x16mm
• E494761808STM1: ZOLID-SHT multilayer D2/D3 98x14mm
• E494761806STM1: ZOLID-SHT multilayer C3/C4 98x20mm
• E494761805STM1: ZOLID-SHT multilayer C3/C4 98x16mm
• E494761804STM1: ZOLID-SHT multilayer C3/C4 98x14mm
• E494761802STM1: ZOLID-SHT multilayer C1/C2 98x20mm
• E494761801STM1: ZOLID-SHT multilayer C1/C2 98x16mm
• E494761800STM1: ZOLID-SHT multilayer C17C2 98x14mm
• E494761798STM1: ZOLID-SHT multilayer B3/B4 98x20mm
• E494761797STM1: ZOLID-SHT multilayer B3/B4 98x16mm