FLEXITIME DYNAMIX HT REFILL 1X(2X380ml) 60035992

GUDID J014600359920

Material Impression

Heraeus Kulzer GmbH

Polyether dental impression material Polyether dental impression material Polyether dental impression material Polyether dental impression material Polyether dental impression material Polyether dental impression material Polyether dental impression material Polyether dental impression material Polyether dental impression material Polyether dental impression material Polyether dental impression material Polyether dental impression material Polyether dental impression material Polyether dental impression material Polyether dental impression material Polyether dental impression material Polyether dental impression material

• Primary Device ID: J014600359920
• NIH Device Record Key: 18637d4a-bad2-4445-9beb-af7876d9f5f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLEXITIME DYNAMIX HT REFILL 1X(2X380ml)
• Version Model Number: 60035992
• Catalog Number: 60035992
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J014600359920 [Primary]

FDA Product Code

• ELW: MATERIAL, IMPRESSION

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: 2023-10-30
• Device Publish Date: 2016-09-23

On-Brand Devices [FLEXITIME DYNAMIX HT REFILL 1X(2X380ml)]

• J014600359921: Dental Composite resin
• J014600359920: Material Impression
• J014400039910: Material, Impression