Vision-Zirkon 2121

GUDID EWOH21211

Vision-Zirkon Transpa Neutral 50g

WOHLWEND AG DENTAL MANUFAKTUR

Dental appliance fabrication material, ceramic

• Primary Device ID: EWOH21211
• NIH Device Record Key: 41a6938f-0e93-41ad-80bf-7b69ed9eb8ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vision-Zirkon
• Version Model Number: 2121
• Catalog Number: 2121
• 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	EWOH21211 [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: 2018-11-12

On-Brand Devices [Vision-Zirkon ]

• EWOH24951: Vision-Zirkon Shade guide Bleach
• EWOH24941: Vision-Zirkon Shade guide Chroma/Mamelon
• EWOH24931: Vision-Zirkon Shade guide Shoulder/OD/G
• EWOH24921: Vision-Zirkon Shade guide Transpa
• EWOH24911: Vision-Zirkon Shade guide Incisal
• EWOH24901: Vision-Zirkon Shade guide Dentin
• EWOH24751: Vision-Zirkon Ingot TC1 5g 5pc
• EWOH24741: Vision-Zirkon Ingot TC1 5g 1pc
• EWOH24721: Vision-Zirkon Ingot TD2 5g 5pc
• EWOH24711: Vision-Zirkon Ingot TD2 5g 1pc
• EWOH24691: Vision-Zirkon Ingot TC2 5g 5pc
• EWOH24681: Vision-Zirkon Ingot TC2 5g 1pc
• EWOH24661: Vision-Zirkon Ingot TB3 5g 5pc
• EWOH24651: Vision-Zirkon Ingot TB3 5g 1pc
• EWOH24631: Vision-Zirkon Ingot TB2 5g 5pc
• EWOH24621: Vision-Zirkon TB2 5g 1pc
• EWOH24601: Vision-Zirkon Ingot TB1 5g 5pc
• EWOH24591: Vision-Zirkon Ingot TB1 5g 1pc
• EWOH24571: Vision-Zirkon Ingot TA3 5g 5pc
• EWOH24561: Vision-Zirkon Ingot TA3 5g 1pc
• EWOH24541: Vision-Zirkon Ingot TA2 5g 5pc
• EWOH24531: Vision-Zirkon Ingot TA2 5g 1pc
• EWOH24511: Vision-Zirkon Ingot TA1 5g 5pc
• EWOH24501: Vision-Zirkon TA1 5g 1pc
• EWOH24061: Vision-Zirkon Ingot TC1 10pc
• EWOH24051: Vision-Zirkon Ingot TC1 5pc
• EWOH24041: Vision-Zirkon Ingot TC1 1pc
• EWOH24031: Vision-Zirkon Ingot TD2 10pc
• EWOH24021: Vision-Zirkon Ingot TD2 5pc
• EWOH24011: Vision-Zirkon Ingot TD2 1pc
• EWOH24001: Vision-Zirkon Ingot TC2 10pc
• EWOH23991: Vision-Zirkon Ingot TC2 5pc
• EWOH23981: Vision-Zirkon Ingot TC2 1pc
• EWOH23971: Vision-Zirkon Ingot TB3 10pc
• EWOH23961: Vision-Zirkon Ingot TB3 5pc
• EWOH23951: Vision-Zirkon Ingot TB3 1pc
• EWOH23941: Vision-Zirkon Ingot TB2 10pc
• EWOH23931: Vision-Zirkon Ingot TB2 5pc
• EWOH23921: Vision-Zirkon Ingot TB2 1pc
• EWOH23911: Vision-Zirkon Ingot TB1 10pc
• EWOH23901: Vision-Zirkon Ingot TB1 5pc
• EWOH23891: Vision-Zirkon Ingot TB1 1pc
• EWOH23881: Vision-Zirkon Ingot TA3 10pc
• EWOH23871: Vision-Zirkon Ingot TA3 5pc
• EWOH23861: Vision-Zirkon Ingot TA3 1pc
• EWOH23851: Vision-Zirkon Ingot TA2 10pc
• EWOH23841: Vision-Zirkon Ingot TA2 5pc
• EWOH23831: Vision-Zirkon Ingot TA2 1pc
• EWOH23821: Vision-Zirkon Ingot TA1 10pc
• EWOH23811: Vision-Zirkon Ingot TA1 5pc