Flexitime 66100481

GUDID J014661004810

Flexitime unlimited Jumbo Pack 12x50ml

Kulzer GmbH

Polyether dental impression material

• Primary Device ID: J014661004810
• NIH Device Record Key: 0c8fbe88-c88d-4e00-8c46-c543a92e47d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flexitime
• Version Model Number: 66100481
• Catalog Number: 66100481
• 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: false
• 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(574)291-0661
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(574)291-0661
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(574)291-0661
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(574)291-0661
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(574)291-0661
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(574)291-0661
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(574)291-0661
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(574)291-0661
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(574)291-0661
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(574)291-0661
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(574)291-0661
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(574)291-0661
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(574)291-0661
• Email: customerservice.na@kulzer-dental.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J014661004810 [Primary]

FDA Product Code

• ELW: MATERIAL, IMPRESSION

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-18
• Device Publish Date: 2025-06-10

On-Brand Devices [Flexitime]

• J014661004810: Flexitime unlimited Jumbo Pack 12x50ml
• J014660993210: Flexitime unlimited Trial Kit
• J014660993200: Flexitime unlimited 1x50ml
• J014660993190: Flexitime unlimited Dynamix Trial Kit
• J014660993180: Flexitime unlimited 1 x (2x50ml)
• J014660993170: Flexitime unlimited Dynamix Refill (1x2x380ml)