Visalys Temp 13780

GUDID E217137801

Visalys Temp A1 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: E217137801
• NIH Device Record Key: e3e834ae-3fd0-4fa5-b390-6e25b47b9309
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visalys Temp
• Version Model Number: 13780
• Catalog Number: 13780
• 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	E217137801 [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

On-Brand Devices [Visalys Temp]

• E217137981: Visalys Temp A3 Superbulk
• E217137951: Visalys Temp A3 Bonus pack
• E217137941: Visalys Temp A2 Bonus pack
• 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