Palaseal, 2 x 15ml 64708063

GUDID J014647080630

Resin, denture, relining, repairing,rebasing

Kulzer GmbH

Dental appliance fabrication material, thermoplastic

• Primary Device ID: J014647080630
• NIH Device Record Key: 5f7203d3-f1b0-48a2-a0be-a8c53ab36aea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Palaseal, 2 x 15ml
• Version Model Number: 64708063
• Catalog Number: 64708063
• 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: 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	J014647080630 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K892452

FDA Product Code

• EBI: RESIN, DENTURE, RELINING, REPAIRING, REBASING

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: 2024-10-30
• Device Publish Date: 2016-09-15

Devices Manufactured by Kulzer GmbH

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• J01466081673 - Dima: 2024-11-07 dima Print Denture - Dark Pink
• J01466081678 - Dima: 2024-11-07 dima Print Denture Teeth - B1
• J01466087415 - Dima: 2024-11-07 dima Print Denture Teeth - BL1
• J014661002680 - VENUS Diamond FLOW: 2024-11-01 VENUS Diamond FLOW SYR 1 x 1,8G - LIGHT
• J014661002690 - VENUS Diamond FLOW: 2024-11-01 VENUS Diamond FLOW SYR 1 x 1,8G - MEDIUM
• J014661002700 - VENUS Diamond FLOW: 2024-11-01 VENUS Diamond FLOW SYR 1 x 1,8G - DARK
• J014661002710 - VENUS Diamond FLOW: 2024-11-01 VENUS Diamond FLOW SYR 1 x 1,8G - BLEACH