Vision-Clasic 406

GUDID EWOH4061

Vision-Classic Vis-Opak White 920° 4g

WOHLWEND AG DENTAL MANUFAKTUR

Dental appliance fabrication material, ceramic

• Primary Device ID: EWOH4061
• NIH Device Record Key: dcc3f7ad-0cf8-42bf-96fd-4359feaa1cbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vision-Clasic
• Version Model Number: 406
• Catalog Number: 406
• 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	EWOH4061 [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: 2018-09-12

On-Brand Devices [Vision-Clasic ]

• EWOH4061: Vision-Classic Vis-Opak White 920° 4g
• EWOH2801: Vision-Classic Shoulder Straw 20g
• EWOH2471: Vision-Classic Transpa Red
• EWOH1241: Vision-Classic Opaquer C3 50g
• EWOH10361: Vision-Classic Dentin A0 50g