Vision-LDL 1797

GUDID EWOH17971

Vision-LDL Mamelon Sunset 50g

WOHLWEND AG DENTAL MANUFAKTUR

Dental appliance fabrication material, ceramic

• Primary Device ID: EWOH17971
• NIH Device Record Key: 594a4859-2bc2-411b-b0a3-d6b9947419ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vision-LDL
• Version Model Number: 1797
• Catalog Number: 1797
• 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	EWOH17971 [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: 2020-03-06
• Device Publish Date: 2020-02-27

On-Brand Devices [Vision-LDL]

• EWOH17691: Vision-LDL Dentin Bleach 2 50g
• EWOH17681: Vision-LDL Dentin Bleach 2 20g
• EWOH17521: Vision-LDL Incisal 58 20g
• EWOH17511: Vision-LDL Incisal 57 50g
• EWOH17501: Vision-LDL Incisal 57 20g
• EWOH17431: Vision-LDL Opak Dentin Honey 50g
• EWOH17421: Vision-LDL Opak Dentin Honey 20g
• EWOH17411: Vision-LDL Opak Dentin White 50g
• EWOH17401: Vision-LDL Opak Dentin White 20g
• EWOH17331: Vision-LDL Dentin Bleach 1 50g
• EWOH17321: Vision-LDL Dentin Bleach 1 20g
• EWOH17311: Vision-LDL Dentin D-D4 50g
• EWOH17301: Vision-LDL Dentin D-D4 20g
• EWOH17291: Vision-LDL Dentin D-D3 50g
• EWOH17281: Vision-LDL Dentin D-D3 20g
• EWOH17271: Vision-LDL Dentin D-D2 50g
• EWOH17261: Vision-LDL Dentin D-D2 20g
• EWOH17251: Vision-LDL Dentin D-C4 50g
• EWOH17241: Vision-LDL Dentin D-C4 20g
• EWOH17231: Vision-LDL Dentin D-C3 50g
• EWOH17221: Vision-LDL Dentin D-C3 20g
• EWOH17211: Vision-LDL Dentin D-C2 50g
• EWOH17201: Vision-LDL Dentin D-C2 20g
• EWOH17191: Vision-LDL Dentin D-C1 50g
• EWOH17181: Vision-LDL Dentin D-C1 20g
• EWOH17171: Vision-LDL Dentin D-B4 50g
• EWOH17161: Vision-LDL Dentin D-B4 20g
• EWOH17151: Vision-LDL Dentin D-B3 50g
• EWOH17141: Vision-LDL Dentin D-B3 20g
• EWOH17131: Vision-LDL Dentin D-B2 50g
• EWOH17121: Vison-LDL Dentin D-B2 20g
• EWOH17111: Vision-LDL Dentin D-B1 50g
• EWOH17101: Vision-LDL Dentin D-B1 20g
• EWOH17081: Vision-LDL Dentin D-A4 20g
• EWOH17071: Vision-LDL Dentin D-A3,5 50g
• EWOH17061: Vision-LDL Dentin D-A3,5 20g
• EWOH17051: Vision-LDL Dentin D-A3 50g
• EWOH17041: Vision-LDL Dentin D-A3 20g
• EWOH17031: Vision-LDL
• EWOH17021: Vision-LDL Dentin D-A2 20g
• EWOH17011: Vision-LDL Dentin D-A1 50g
• EWOH17001: Vision-LDL Dentin D-A1 20g
• EWOH18301: Vision-LDL Shade guide Mamelon/Gingiva
• EWOH18291: Vision-LDL Shade guide Opak-Dentin/Bleach
• EWOH18281: Vision-LDL Shade guide Transpa
• EWOH18271: Vision-LDL Shade guide Incisal
• EWOH18261: Vision-LDL Shade guide Dentin
• EWOH18231: Vision-LDL Testkit A3 105g
• EWOH18221: Vision-LDL Assortment S3 125g
• EWOH18211: Vision-LDL Assortment S2 330g