VENUS PEARL PLT REFILL 20x0,2G A4 66048145

GUDID J014660481450

Dental Composite resin

Kulzer GmbH

Dental composite resin

• Primary Device ID: J014660481450
• NIH Device Record Key: 840c2c73-d04e-4fb6-8db5-035d095d92b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VENUS PEARL PLT REFILL 20x0,2G A4
• Version Model Number: 66048145
• Catalog Number: 66048145
• 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
• 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	J014660481450 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112501

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: 2016-09-23

Devices Manufactured by Kulzer GmbH

• J014660164550 - Starlight pro: 2026-02-05 Glare shield, orange
• J014660573650 - Starlight pro: 2026-02-05 Light guide, 8mm, 70°
• J014660968300 - Starlight pro: 2026-02-05 Starlight pro
• J014660969290 - Starlight pro: 2026-02-05 Light guide, 8mm, 45°
• J014660971690 - Starlight pro: 2026-02-05 Hand piece incl. rechargeable battery
• J014660971700 - Starlight pro: 2026-02-05 Charger unit
• J014661012160 - iCEM Universal Plus: 2026-01-23 iCEM Universal Plus Mixing Tips
• J014661012170 - iCEM Universal Plus: 2026-01-23 iCEM Universal Plus Cement Opaque