GLUMA COMFORT BOND+DESENSIT.SD 40X1 PCE. 66005664

GUDID J014660056640

Agent, tooth bonding resin

Heraeus Kulzer GmbH

Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set

• Primary Device ID: J014660056640
• NIH Device Record Key: eeaaa3d9-10b4-447c-9806-5bfb46816ae8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GLUMA COMFORT BOND+DESENSIT.SD 40X1 PCE.
• Version Model Number: 66005664
• Catalog Number: 66005664
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J014660056640 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992292

FDA Product Code

• KLE: AGENT, TOOTH BONDING, RESIN

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

Devices Manufactured by Heraeus Kulzer GmbH

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• J014660354850 - Venus Diamond: 2024-03-14 VENUS DIAMOND SYRINGE REFILL 1x4G OM
• J014660354860 - Venus Diamond: 2024-03-14 VENUS DIAMOND SYRINGE REFILL 1x4G OD
• J014660390210 - Venus Diamond: 2024-03-14 VENUS DIAMOND PLT REFILL 1x10x0,25G OL
• J014660390220 - Venus Diamond: 2024-03-14 VENUS DIAMOND PLT REFILL 2x10x0,25G OM
• J014660390230 - Venus Diamond: 2024-03-14 VENUS DIAMOND PLT REFILL 2x10x0,25G OD
• J014660982750 - Venus Diamond: 2024-03-14 PROC Venus Diamond Kit 2x20X0.25G PLT
• J014660982760 - Venus Pearl: 2024-03-14 PROC Venus Pearl Kit 2x20X0.2G PLT