VENUS Diamond FLOW 66100306

GUDID J014661003060

PROC Venus Diamond Flow Kit 2x1.8G SYR

Kulzer GmbH

Dental composite resin

• Primary Device ID: J014661003060
• NIH Device Record Key: 436f8235-7e4f-4880-8682-ce90711106d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VENUS Diamond FLOW
• Version Model Number: 66100306
• Catalog Number: 66100306
• Company DUNS: 315666321
• Company Name: Kulzer GmbH
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: +1(800)431-1785
• Email: xxx@xxx.xx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J014661003060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091635

FDA Product Code

• EBC: SEALANT, PIT AND FISSURE, AND CONDITIONER

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: 2024-11-01
• Device Publish Date: 2024-10-24

On-Brand Devices [VENUS Diamond FLOW]

• J014661003060: PROC Venus Diamond Flow Kit 2x1.8G SYR
• J014661002750: VENUS Diamond FLOW PLT 20x0,20g - BLEACH
• J014661002740: VENUS Diamond FLOW PLT 20x0,20g - DARK
• J014661002730: VENUS Diamond FLOW PLT 20x0,20g - MEDIUM
• J014661002720: VENUS Diamond FLOW PLT 20x0,20g - LIGHT
• J014661002710: VENUS Diamond FLOW SYR 1 x 1,8G - BLEACH
• J014661002700: VENUS Diamond FLOW SYR 1 x 1,8G - DARK
• J014661002690: VENUS Diamond FLOW SYR 1 x 1,8G - MEDIUM
• J014661002680: VENUS Diamond FLOW SYR 1 x 1,8G - LIGHT