Vision 443

GUDID EWOH4431

Vision brush 00 (synthetic)

WOHLWEND AG DENTAL MANUFAKTUR

Dental appliance fabrication material, ceramic

• Primary Device ID: EWOH4431
• NIH Device Record Key: 6f176360-ee4b-45dd-abb8-d6f92224052a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vision
• Version Model Number: 443
• Catalog Number: 443
• 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 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EWOH4431 [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: 2020-03-12
• Device Publish Date: 2020-03-04

On-Brand Devices [Vision]

• EWOH991: Vision Brennwatte/Liquid firing tray 10ml
• EWOH4481: Vision brush F01 (synthetic)
• EWOH4471: Vision brush 08 (synthetic)
• EWOH4461: Vision brush 06 (synthetic)
• EWOH4451: Vision brush 04 (synthetic)
• EWOH4441: Vision brush 02 (synthetic)
• EWOH4431: Vision brush 00 (synthetic)
• EWOH3741: Vision-Bonding 6gr
• EWOH3631: Vision Isolierstift/Ceramic Seperator-pen 5ml
• EWOH3621: Vision brush set in Woodenbox
• EWOH3611: Vision brush set (00/02/04/06/08/F01)