PALA cre-active, maroon, 3 g 66033461

GUDID J014660334610

Material tooth shade resin

Kulzer GmbH

Dental appliance fabrication material, thermoplastic

• Primary Device ID: J014660334610
• NIH Device Record Key: e5120ee9-1f05-4034-917f-dbf3bf93d719
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PALA cre-active, maroon, 3 g
• Version Model Number: 66033461
• Catalog Number: 66033461
• 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	J014660334610 [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

• J014647141980 - Signum liquid: 2024-11-29 Signum liquid, 4 ml
• J014660196750 - Signum matrix: 2024-11-29 Signum matrix (set)
• J014660196770 - Signum matrix: 2024-11-29 Signum matrix, OT1, 4 g
• J014660196780 - Signum matrix: 2024-11-29 Signum matrix, OT2, 4 g
• J014660196790 - Signum matrix: 2024-11-29 Signum matrix, OT5, 4 g
• J014660196800 - Signum matrix: 2024-11-29 Signum matrix, OT10, 4 g
• J014660196910 - Signum matrix: 2024-11-29 Signum matrix, MD1, 4 g
• J014660196920 - Signum matrix: 2024-11-29 Signum matrix, MD2, 4 g