Vision-Classi 351

GUDID EWOH3511

Vision-Classic Stain Glaze 3g

WOHLWEND AG DENTAL MANUFAKTUR

Dental appliance fabrication material, ceramic

• Primary Device ID: EWOH3511
• NIH Device Record Key: f1edbc3a-5209-435b-8b86-77d82c0e1cd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vision-Classi
• Version Model Number: 351
• Catalog Number: 351
• 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	EWOH3511 [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: 2018-09-06

On-Brand Devices [Vision-Classi]

• EWOH4721: Vision-Classic Opaquer Liquid - 2 250ml
• EWOH3511: Vision-Classic Stain Glaze 3g