Visalys Veneer 28415S

GUDID E21728415S1

Visalys Veneer Size S, Upper/OK 15/US4

Kettenbach GmbH & Co. KG

Dental composite resin

• Primary Device ID: E21728415S1
• NIH Device Record Key: 58378c90-7c3c-4325-9dc0-1a0a070e0bb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visalys Veneer
• Version Model Number: 28415S
• Catalog Number: 28415S
• 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	E21728415S1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982692

FDA Product Code

• EBF: Material, Tooth Shade, 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: 2016-09-19

On-Brand Devices [Visalys Veneer]

• E217284701: Visalys Veneer Starter Set
• E217284601: Visalys Veneer Bond
• E217284561: Visalys Veneer Composite Mix
• E217284551: Visalys Veneer Composite Enamel
• E217284541: Visalys Veneer Composite A3.5
• E217284531: Visalys Veneer Composite A3
• E217284521: Visalys Veneer Composite A2
• E217284511: Visalys Veneer Composite A1
• E217284501: Visalys Veneer Composite BL
• E21728445S1: Visalys Veneer Size S, Lower/UK 45/US29
• E21728445M1: Visalys Veneer Size M, Lower/UK 45/US29
• E21728444S1: Visalys Veneer Size S, Lower/UK 44/US28
• E21728444M1: Visalys Veneer Size M, Lower/UK 44/US28
• E21728443S1: Visalys Veneer Size S, Lower/UK 43/US27
• E21728443M1: Visalys Veneer Size M, Lower/UK 43/US27
• E21728442S1: Visalys Veneer Size S, Lower/UK 42/US26
• E21728442M1: Visalys Veneer Size M, Lower/UK 42/US26
• E21728441S1: Visalys Veneer Size S, Lower/UK 41/US25
• E21728441M1: Visalys Veneer Size M, Lower/UK 41/US25
• E21728435S1: Visalys Veneer Size S, Lower/UK 35/US20
• E21728435M1: Visalys Veneer Size M, Lower/UK 35/US20
• E21728434S1: Visalys Veneer Size S, Lower/UK 34/US21
• E21728434M1: Visalys Veneer Size M, Lower/UK 34/US21
• E21728433S1: Visalys Veneer Size S, Lower/UK 33/US22
• E21728433M1: Visalys Veneer Size M, Lower/UK 33/US22
• E2172843343S1: Visalys Veneer Size S, Lower/UK 33-43/US22-US27
• E2172843343M1: Visalys Veneer Size M, Lower/UK 33-43/US22-US27
• E21728432S1: Visalys Veneer Size S, Lower/UK 32/US23
• E21728432M1: Visalys Veneer Size M, Lower/UK 32/US23
• E21728431S1: Visalys Veneer Size S, Lower/UK 31/US24
• E21728431M1: Visalys Veneer Size M, Lower/UK 31/US24
• E21728425S1: Visalys Veneer Size S, Upper/OK 25/US13
• E21728425M1: Visalys Veneer Size M, Upper/OK 25/US13
• E21728425L1: Visalys Veneer Size L, Upper/OK 25/US13
• E21728424S1: Visalys Veneer Size S, Upper/OK 24/US12
• E21728424M1: Visalys Veneer Size M, Upper/OK 24/US12
• E21728424L1: Visalys Veneer Size L, Upper/OK 24/US12
• E21728423S1: Visalys Veneer Size S, Upper/OK 23/US11
• E21728423M1: Visalys Veneer Size M, Upper/OK 23/US11
• E21728423L1: Visalys Veneer Size L, Upper/OK 23/US11
• E21728422S1: Visalys Veneer Size S, Upper/OK 22/US10
• E21728422M1: Visalys Veneer Size M, Upper/OK 22/US10
• E21728422L1: Visalys Veneer Size L, Upper/OK 22/US10
• E21728421S1: Visalys Veneer Size S, Upper/OK 21/US9
• E21728421M1: Visalys Veneer Size M, Upper/OK 21/US9
• E21728421L1: Visalys Veneer Size L, Upper/OK 21/US9
• E21728415S1: Visalys Veneer Size S, Upper/OK 15/US4
• E21728415M1: Visalys Veneer Size M, Upper/OK 15/US4
• E21728415L1: Visalys Veneer Size L, Upper/OK 15/US4
• E21728414S1: Visalys Veneer Size S, Upper/OK 14/US5