Vision-3D Artistic 761

GUDID EWOH7611

Vision-3D Artistic Sculpture Inicsal 5g

WOHLWEND AG DENTAL MANUFAKTUR

Dental appliance fabrication material, ceramic

• Primary Device ID: EWOH7611
• NIH Device Record Key: f9f46600-aece-4a2e-881b-49f1c83f4711
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vision-3D Artistic
• Version Model Number: 761
• Catalog Number: 761
• 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	EWOH7611 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-20
• Device Publish Date: 2019-11-12

On-Brand Devices [Vision-3D Artistic ]

• EWOH7701: Vision-3D Artistic Assortment 95g
• EWOH7691: Vison-3D Artistic Glaze Fluid 25ml
• EWOH7631: Vision-3D Artistic Sculpture Arctic-Blue 5g
• EWOH7621: Vision-3D Artistic Sculpture Opal 5g
• EWOH7611: Vision-3D Artistic Sculpture Inicsal 5g
• EWOH7601: Vision-3D Artistic Sculpture Clear 5g
• EWOH7551: Vision-3D Artistic Flour Glaze 5g
• EWOH7541: Vision-3D Artistic Mamelon Ivory 3g
• EWOH7531: Vision-3D Artistic Stain Gray 3g
• EWOH7521: Vision-3D Artistic Sain Blue 3g
• EWOH7511: Vision-3D Artistic Stain Violet 3g
• EWOH7501: Vision-3D Artistic Stain Pink 3g
• EWOH7491: Vision-3D Artistic Stain Red 3g
• EWOH7481: Vision-3D Artistic Stain Darkbrown 3g
• EWOH7471: Vision-3D Artistic Stain Redbrown 3g
• EWOH7461: Vision-3D Artistic Stain Olive 3g
• EWOH7451: Vision-3D Artistic Stain Honey 3g
• EWOH7441: Vision-3D Artistic Stain White 3g
• EWOH7431: Vision-3D Artistic Shade D 3g
• EWOH7421: Vision-3D Artisic Shade C 3g
• EWOH7411: Vision-3D Artistic Shade B 3g
• EWOH7401: Vision-3D Artistic Shade A 3g