UltraThineer BMF-5YZ-1.6B

GUDID 00860012810802

BMF Precision Inc.

Dental appliance fabrication material, ceramic

• Primary Device ID: 00860012810802
• NIH Device Record Key: b7cb3633-6429-4e79-a6c6-0d785e8f218f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraThineer
• Version Model Number: Zirconia 5Y Slurry
• Catalog Number: BMF-5YZ-1.6B
• Company DUNS: 117405247
• Company Name: BMF Precision Inc.
• 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: false
• Lot Batch: true
• Serial Number: false
• 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
GS1	00860012810802 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240419

FDA Product Code

• EIH: Powder, Porcelain

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: 2024-10-09
• Device Publish Date: 2024-10-01