Visalys Bulk

GUDID E217150681

Visalys Bulk Intro pack, 2 x 0,25g Visalys Bulk Fill Caps, 2 x 0,25g Visalys Bulk Flow Caps

Kettenbach GmbH & Co. KG

Dental composite resin

• Primary Device ID: E217150681
• NIH Device Record Key: 4c09d189-ef3d-4a05-9b8a-1f48757f8488
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visalys Bulk
• Version Model Number: 15068
• 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

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	E217150681 [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

Devices Manufactured by Kettenbach GmbH & Co. KG

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• E217150621 - Visalys Bulk Fill: 2026-03-13 Visalys Bulk Fill, 15 x 0,25g Caps
• E217150681 - Visalys Bulk: 2026-03-13Visalys Bulk Intro pack, 2 x 0,25g Visalys Bulk Fill Caps, 2 x 0,25g Visalys Bulk Flow Caps
• E217150681 - Visalys Bulk: 2026-03-13 Visalys Bulk Intro pack, 2 x 0,25g Visalys Bulk Fill Caps, 2 x 0,25g Visalys Bulk Flow Caps
• E217150751 - Visalys BioCeramic Block: 2026-01-27 Visalys BioCeramic Block Starter pack
• E217150851 - Visalys BioCeramic Block: 2026-01-27 Visalys BioCeramic Block Implant Chroma
• E217150701 - Visalys BioCeramic Block: 2026-01-19 Visalys BioCeramic Block Translucent
• E217150711 - Visalys BioCeramic Block: 2026-01-19 Visalys BioCeramic Block Chroma