Zubler

GUDID 08800118626558

U&C International Co.,Ltd

Dental appliance fabrication material, ceramic

• Primary Device ID: 08800118626558
• NIH Device Record Key: 2df39c02-14e3-4b4d-88c0-373392ebf38a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zubler
• Version Model Number: W 1100 AA2 10
• Company DUNS: 694821663
• Company Name: U&C International Co.,Ltd
• 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: true
• Expiration Date: false
• 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	08800118626558 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191902

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: 2023-03-13
• Device Publish Date: 2023-03-03

On-Brand Devices [Zubler]

• 08800118626664: W 1100 ABL3 30
• 08800118626657: W 1100 ABL3 25
• 08800118626640: W 1100 AA2 30
• 08800118626633: W 1100 AA2 28
• 08800118626626: W 1100 AA2 25
• 08800118626619: W 1100 AA2 22
• 08800118626602: W 1100 AA2 20
• 08800118626596: W 1100 AA2 18
• 08800118626589: W 1100 AA2 16
• 08800118626572: W 1100 AA2 14
• 08800118626565: W 1100 AA2 12
• 08800118626558: W 1100 AA2 10