Vision-Classic 391

GUDID EWOH3911

Vision-Classic Vis-Opak A2 920°C 4g

WOHLWEND AG DENTAL MANUFAKTUR

Dental appliance fabrication material, ceramic

• Primary Device ID: EWOH3911
• NIH Device Record Key: ca1ef64e-5f91-459e-a26a-db472b9c75e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vision-Classic
• Version Model Number: 391
• Catalog Number: 391
• 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	EWOH3911 [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-Classic]

• EWOH6131: Vision-Classic Neck Brown 50g
• EWOH6121: Vision-Classic Neck Brown 20g
• EWOH6111: Vision-Classic Neck Straw 50g
• EWOH6101: Vision-Classic Neck Straw 20g
• EWOH6051: Vision-Classic Opaquer Gingiva 50g
• EWOH6041: Vision-Classic Opaquer Gingiva 20g
• EWOH6031: Vision-Classic Gingival Darkred 50g
• EWOH6021: Vision-Classic Gingival Darkred 20g
• EWOH6011: Vision-Classic Gingival Lightred 50g
• EWOH6001: Vision-Classic Gingival Lightred 20g
• EWOH4711: Vision-Classic Opaquer Liquid - 2 50ml
• EWOH4701: Vision-Classic Opaquer Liquid - 2 25ml
• EWOH4571: Vision-Classic Opaquer Liquid Repair 25ml
• EWOH4561: Vision-Classic Modelling Liquid Repair 25ml
• EWOH4551: Vision-Classic Stain Repair 3g
• EWOH4541: Vision-Classic Transpa Repair 20g
• EWOH4531: Vision-Classic Incisal Repair 20g
• EWOH4521: Vision-Classic Dentin Repair 20g
• EWOH4511: Vision-Classic Opaquer Repair 20g
• EWOH4421: Vision-Classic Opaquer Liquid 1Lt.
• EWOH4411: Vision-Classic Opaquer D4 250gq
• EWOH4401: Vision-Classic Opaquer D3 250g
• EWOH4391: Vision-Classic Opaquer D2 250g
• EWOH4381: Vision-Classic Opaquer C4 250g
• EWOH4371: Vision-Classic Opaquer C3 250g
• EWOH4361: Vision-Classic Opaquer C2 250g
• EWOH4351: Vision-Classic Opaquer C1 250g
• EWOH4341: Vision-Classic Opaquer B4 250g
• EWOH4331: Vision-Classic Opaquer B3 250g
• EWOH4321: Vision-Classic Opaquer B2 250g
• EWOH4311: Vision-Classic Opaquer B1 250g
• EWOH4301: Vision-Classic Opaquer A4 250g
• EWOH4291: Vision-Classic Opaquer A3,5 250g
• EWOH4281: Vision-Classic Opaquer A3 250g
• EWOH4271: Vision-Classic Opaquer A2 250g
• EWOH4261: Vision-Classic Opaquer A1 250g
• EWOH4221: Vision-Classic Glaze 40g
• EWOH4191: Vision-Classic Glaze & Stain Liquid 1Lt.
• EWOH4181: Vision-Classic Glaze & Stain Liquid 250ml
• EWOH4151: Vision-Classic Transpa Superclear 250g
• EWOH4141: Vision-Classic Transpa Superclear 50g
• EWOH4131: Vision-Classic Transpa Superclear 20g
• EWOH4121: Vision-Classic Stain Grey 3g
• EWOH4101: Vision-Classic Vis-Opak Liquid 920° 10ml
• EWOH4091: Vision-Classic Vis-Opak Violett 920° 4g
• EWOH4071: Vision-Classic Vis-Opak Ocher 920° 4g
• EWOH4051: Vision-Classic Vis-Opak D4 920° 4g
• EWOH4041: Vision-Classic Vis-Opak D3 920° 4g
• EWOH4031: Vision-Classic Vis-Opak D2 920° 4g
• EWOH4021: Vision-Classic Vis-Opak C4 920° 4g