TRANSLUX® POWER BLUE® USA/JP/MEX 66017507

GUDID J014660175070

Activator, ultraviolent, for polymerization

Heraeus Kulzer GmbH

Dental/surgical polymerization lamp

• Primary Device ID: J014660175070
• NIH Device Record Key: ebb13b45-a7aa-4216-9bba-c7013fc92e7a
• Commercial Distribution Discontinuation: 2024-08-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: TRANSLUX® POWER BLUE® USA/JP/MEX
• Version Model Number: 66017507
• Catalog Number: 66017507
• 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: true
• 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	J014660175070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042199

FDA Product Code

• EBZ: ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

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: 2024-08-28
• Device Publish Date: 2016-09-15

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• J014657670380 - CUTTERSIL P PLUS 1X900 ML: 2024-09-17 Material, Impression
• J014658179300 - CUTTERSIL LIGHT GREEN 1X140 ML: 2024-09-17 Material, Impression
• J014660007810 - Dispensing Gun 4:1: 2024-09-17 Instruments, Dental Hand
• J014660007821 - IOT yellow 96: 2024-09-17 Syringe, Restorative and Impression Material
• J014660009051 - BITE REG INTRAORAL TIP CD 96: 2024-09-17 Syringe, Restorative and Impression Material