Fasthetix Liquid Starter Essential 761397

GUDID E4947613971

Amann Girrbach AG

Dental appliance fabrication material, ceramic

• Primary Device ID: E4947613971
• NIH Device Record Key: 4f07e811-6361-4d6f-acf7-9277991e8025
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fasthetix Liquid Starter Essential
• Version Model Number: Fasthetix Liquid Starter Essential
• Catalog Number: 761397
• 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: +4355236333105
• Email: austria@amanngirbach.com
• Phone: +4355236333105
• Email: austria@amanngirbach.com
• Phone: +4355236333105
• Email: austria@amanngirbach.com
• Phone: +4355236333105
• Email: austria@amanngirbach.com
• Phone: +4355236333105
• Email: austria@amanngirbach.com
• Phone: +4355236333105
• Email: austria@amanngirbach.com
• Phone: +4355236333105
• Email: austria@amanngirbach.com
• Phone: +4355236333105
• Email: austria@amanngirbach.com
• Phone: +4355236333105
• Email: austria@amanngirbach.com
• Phone: +4355236333105
• Email: austria@amanngirbach.com
• Phone: +4355236333105
• Email: austria@amanngirbach.com
• Phone: +4355236333105
• Email: austria@amanngirbach.com
• Phone: +4355236333105
• Email: austria@amanngirbach.com
• Phone: +4355236333105
• Email: austria@amanngirbach.com
• Phone: +4355236333105
• Email: austria@amanngirbach.com
• Phone: +4355236333105
• Email: austria@amanngirbach.com
• Phone: +4355236333105
• Email: austria@amanngirbach.com
• Phone: +4355236333105
• Email: austria@amanngirbach.com
• Phone: +4355236333105
• Email: austria@amanngirbach.com
• Phone: +4355236333105
• Email: austria@amanngirbach.com
• Phone: +4355236333105
• Email: austria@amanngirbach.com
• Phone: +4355236333105
• Email: austria@amanngirbach.com
• Phone: +4355236333105
• Email: austria@amanngirbach.com
• Phone: +4355236333105
• Email: austria@amanngirbach.com
• Phone: +4355236333105
• Email: austria@amanngirbach.com
• Phone: +4355236333105
• Email: austria@amanngirbach.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E4947613971 [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: 2
• Public Version Date: 2018-07-24
• Device Publish Date: 2018-03-23

Devices Manufactured by Amann Girrbach AG

• E4947682361 - Zolid Bion: 2025-03-05
• E4947682391 - Zolid Bion: 2025-03-05
• E4947682411 - Zolid Bion: 2025-03-05
• E4947682421 - Zolid Bion: 2025-03-05
• E4947682521 - Zolid Bion: 2025-03-05
• E4947682551 - Zolid Bion: 2025-03-05
• E4947682571 - Zolid Bion: 2025-03-05
• E4947682581 - Zolid Bion: 2025-03-05