iBOND TOTAL ETCH BOTTLE SAMPLE 1 x 2ML 66048262

GUDID J014660482620

Agent, tooth bonding resin, varnish, cavity

Heraeus Kulzer GmbH

Dentine bonding agent/set

• Primary Device ID: J014660482620
• NIH Device Record Key: ef202c6d-8b67-4d24-a18f-e191197850e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iBOND TOTAL ETCH BOTTLE SAMPLE 1 x 2ML
• Version Model Number: 66048262
• Catalog Number: 66048262
• Company DUNS: 315666321
• Company Name: Heraeus 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: 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J014660482620 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083652

FDA Product Code

• LBH: VARNISH, CAVITY

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: 2024-02-16
• Device Publish Date: 2016-09-15

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• J014660007821 - IOT yellow 96: 2024-09-17 Syringe, Restorative and Impression Material
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