Visalys Temp 13784US

GUDID E21713784US1

Visalys Temp B1 USA Normal pack

Kettenbach GmbH & Co. KG

Dental crown/bridge, temporary Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge

• Primary Device ID: E21713784US1
• NIH Device Record Key: 7676dbbb-cbee-43fd-a163-375949835a50
• Commercial Distribution Discontinuation: 2017-01-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Visalys Temp
• Version Model Number: 13784US
• Catalog Number: 13784US
• Company DUNS: 316803246
• Company Name: Kettenbach GmbH & Co. KG
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E21713784US1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122039

FDA Product Code

• EBG: Crown And Bridge, Temporary, Resin

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: 2018-07-06
• Device Publish Date: 2016-09-15

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• E21713790US1: Visalys Temp A3,5 USA Normal pack
• E21713788US1: Visalys Temp BL USA Normal pack
• E217137851: Visalys Temp A3 Intro pack
• E21713784US1: Visalys Temp B1 USA Normal pack
• E217137831: Visalys Temp A3 Sample
• E21713782US1: Visalys Temp A3 USA Normal pack
• E217137821: Visalys Temp A3 Normal pack
• E21713781US1: Visalys Temp A2 USA Normal pack
• E217137811: Visalys Temp A2 Normal pack
• E217137801: Visalys Temp A1 Normal pack