VENUS Diamond FLOW SYR 1 x 1,8G - A4 66040360

GUDID J014660403600

sealant, pit and fissure and conditionar

Kulzer GmbH

Dental pit/fissure sealant

• Primary Device ID: J014660403600
• NIH Device Record Key: a715e2ff-6e16-42d0-9e34-b808e223b529
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VENUS Diamond FLOW SYR 1 x 1,8G - A4
• Version Model Number: 66040360
• Catalog Number: 66040360
• 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: false
• 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.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xxx@xxx.xxx
• Phone: +1(800)431-1785
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(800)431-1785
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(800)431-1785
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(800)431-1785
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(800)431-1785
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(800)431-1785
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(800)431-1785
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(800)431-1785
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(800)431-1785
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(800)431-1785
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(800)431-1785
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(800)431-1785
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(800)431-1785
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(800)431-1785
• Email: customerservice.na@kulzer-dental.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J014660403600 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-10-30
• Device Publish Date: 2016-09-15

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• J014661012220 - iCEM Universal Plus: 2026-01-23 iCEM Universal Plus Cement Value Pack Transparent
• J014661012230 - iCEM Universal Plus: 2026-01-23 iCEM Universal Plus Endo Tips