Visalys CemCore 13576

GUDID E217135761

Visalys CemCore Dark (A4) Normal pack 1 x 5 ml + Accessories

Kettenbach GmbH & Co. KG

Dental composite resin

• Primary Device ID: E217135761
• NIH Device Record Key: 778efe37-88ca-4be1-b8be-b2bf36ee8aec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visalys CemCore
• Version Model Number: 13576
• Catalog Number: 13576
• 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	E217135761 [Primary]

FDA Product Code

• EBF: Material, Tooth Shade, Resin

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: 2019-12-03
• Device Publish Date: 2019-11-25

On-Brand Devices [Visalys CemCore]

• E217135761: Visalys CemCore Dark (A4) Normal pack 1 x 5 ml + Accessories
• E217135751: Visalys CemCore Bleach Normal pack 1 x 5 ml + Accessories
• E217135741: Visalys CemCore Translucent Normal pack 1 x 5 ml + Accessories
• E217135731: Visalys CemCore Opaque Normal pack 1 x 5 ml + Accessories
• E217135721: Visalys CemCore Universal (A2/A3) Normal pack 1 x 5 ml + Accessories
• E21713572: Visalys CemCore Universal (A2/A3) Normal pack 1 x 5 ml + Accessories
• E217135701: Visalys CemCore Universal (A2/A3) Starter pack 1 x 2,5 ml VCC, 2 ml TP, 2 ml RP + Accessories