GLUMA Desensitizer PowerGel 4x1G 66043451

GUDID J014660434510

LBH

Heraeus Kulzer GmbH

Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish

• Primary Device ID: J014660434510
• NIH Device Record Key: a8004db5-7a34-4742-8992-59829a0e5452
• Commercial Distribution Discontinuation: 2024-07-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: GLUMA Desensitizer PowerGel 4x1G
• Version Model Number: 66043451
• Catalog Number: 66043451
• 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: xx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xx@xxx.xxx
• Phone: +1(800)431-1785
• Email: xx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J014660434510 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093575

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: 2024-07-09
• Device Publish Date: 2016-09-15

Devices Manufactured by Heraeus Kulzer GmbH

• J014660434510 - GLUMA Desensitizer PowerGel 4x1G: 2024-07-09LBH
• J014660434510 - GLUMA Desensitizer PowerGel 4x1G: 2024-07-09 LBH
• J014660354840 - Venus Diamond: 2024-03-14 VENUS DIAMOND SYRINGE REFILL 1x4G OL
• 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