PALA cre-active, gingiva, pink 3 g 66033463

GUDID J014660334630

Material tooth shade resin

Kulzer GmbH

Dental appliance fabrication material, thermoplastic

• Primary Device ID: J014660334630
• NIH Device Record Key: f7579a4c-9b92-4bb3-a184-61fc4e8dbaaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PALA cre-active, gingiva, pink 3 g
• Version Model Number: 66033463
• Catalog Number: 66033463
• 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	J014660334630 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K914456

FDA Product Code

• EBF: MATERIAL, TOOTH SHADE, 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: 2024-10-30
• Device Publish Date: 2016-09-15

Devices Manufactured by Kulzer GmbH

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• 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
• J014661002720 - VENUS Diamond FLOW: 2024-11-01 VENUS Diamond FLOW PLT 20x0,20g - LIGHT
• J014661002730 - VENUS Diamond FLOW: 2024-11-01 VENUS Diamond FLOW PLT 20x0,20g - MEDIUM
• J014661002740 - VENUS Diamond FLOW: 2024-11-01 VENUS Diamond FLOW PLT 20x0,20g - DARK
• J014661002750 - VENUS Diamond FLOW: 2024-11-01 VENUS Diamond FLOW PLT 20x0,20g - BLEACH