Ceramill A-Splint 761088

GUDID E4947610881

Amann Girrbach AG

Temporary dental crown/bridge

• Primary Device ID: E4947610881
• NIH Device Record Key: 0ecbbbb4-3488-4888-ac35-b6f23146e141
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ceramill A-Splint
• Version Model Number: Ceramill A-Splint 98x16/10
• Catalog Number: 761088
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E4947610881 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191836

FDA Product Code

• MQC: Mouthguard, Prescription

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: 2026-01-29
• Device Publish Date: 2026-01-21

On-Brand Devices [Ceramill A-Splint]

• E4947610891: Ceramill A-Splint 98x20/10
• E4947610881: Ceramill A-Splint 98x16/10
• E4947610871: Ceramill A-Splint 98x14/10