Vision-Univeral 706

GUDID EWOH7061

Vision-Univeral Stain Powder Olive 3g

WOHLWEND AG DENTAL MANUFAKTUR

Dental appliance fabrication material, ceramic

• Primary Device ID: EWOH7061
• NIH Device Record Key: b89b21e9-7ed1-4f7a-8186-b52797378dfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vision-Univeral
• Version Model Number: 706
• Catalog Number: 706
• Company DUNS: 448037775
• Company Name: WOHLWEND AG DENTAL MANUFAKTUR
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EWOH7061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990790

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: 3
• Public Version Date: 2019-11-04
• Device Publish Date: 2018-11-22

On-Brand Devices [Vision-Univeral]

• EWOH7101: Vision-Universal Stain Powder Blue 3g
• EWOH7071: Vision-Univeral Stain Powder Redbrown 3g
• EWOH7061: Vision-Univeral Stain Powder Olive 3g