Visalys BioCeramic Block 15080

GUDID E217150801

Visalys BioCeramic Block Implant Translucent

Kettenbach GmbH & Co. KG

Dental appliance fabrication material, combination-material

• Primary Device ID: E217150801
• NIH Device Record Key: 37f95a17-3662-4e33-b383-6d7ff9bf5589
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visalys BioCeramic Block
• Version Model Number: 15080
• Catalog Number: 15080
• Company DUNS: 316803246
• Company Name: Kettenbach GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• 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: false
• Manufacturing Date: false
• 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	E217150801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241131

FDA Product Code

• EBF: Material, Tooth Shade, Resin

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: 2026-01-19
• Device Publish Date: 2026-01-09

On-Brand Devices [Visalys BioCeramic Block]

• E217150901: Visalys BioCeramic Block Implant Chroma
• E217150891: Visalys BioCeramic Block Implant Chroma
• E217150881: Visalys BioCeramic Block Implant Chroma
• E217150871: Visalys BioCeramic Block Implant Chroma
• E217150861: Visalys BioCeramic Block Implant Translucent
• E217150841: Visalys BioCeramic Block Implant Chroma
• E217150831: Visalys BioCeramic Block Implant Chroma
• E217150821: Visalys BioCeramic Block Implant Chroma
• E217150811: Visalys BioCeramic Block Implant Chroma
• E217150801: Visalys BioCeramic Block Implant Translucent
• E217150761: Visalys BioCeramic Block Chroma
• E217150741: Visalys BioCeramic Block Chroma
• E217150731: Visalys BioCeramic Block Chroma
• E217150721: Visalys BioCeramic Block Chroma
• E217150711: Visalys BioCeramic Block Chroma
• E217150701: Visalys BioCeramic Block Translucent
• E217150851: Visalys BioCeramic Block Implant Chroma
• E217150751: Visalys BioCeramic Block Starter pack