Visalys Bulk Fill

GUDID E217150601

Visalys Bulk Fill, 1 x 4g Syringe

Kettenbach GmbH & Co. KG

Dental composite resin

• Primary Device ID: E217150601
• NIH Device Record Key: 606ce160-c750-4ddf-ad59-fde03322bce9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visalys Bulk Fill
• Version Model Number: 15060
• 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: 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

Customer Support Contacts

• Phone: +4927747050
• Email: info@kettenbach.com
• Phone: +4927747050
• Email: info@kettenbach.com
• Phone: +4927747050
• Email: info@kettenbach.com
• Phone: +4927747050
• Email: info@kettenbach.com
• Phone: +4927747050
• Email: info@kettenbach.com
• Phone: +4927747050
• Email: info@kettenbach.com
• Phone: +4927747050
• Email: info@kettenbach.com
• Phone: +4927747050
• Email: info@kettenbach.com
• Phone: +4927747050
• Email: info@kettenbach.com
• Phone: +4927747050
• Email: info@kettenbach.com
• Phone: +4927747050
• Email: info@kettenbach.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E217150601 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250267

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: 2026-03-13
• Device Publish Date: 2026-03-05

On-Brand Devices [Visalys Bulk Fill]

• E217150621: Visalys Bulk Fill, 15 x 0,25g Caps
• E217150611: Visalys Bulk Fill Intro pack, 1 x 2g Syringe
• E217150601: Visalys Bulk Fill, 1 x 4g Syringe