Venus Bulk Flow ONE 66095388

GUDID J014660953880

Venus Bulk Flow ONE Value-Kit PLT

Kulzer GmbH

Dental composite resin

• Primary Device ID: J014660953880
• NIH Device Record Key: 936836c7-9965-42bb-8b17-31c777f34a99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venus Bulk Flow ONE
• Version Model Number: 66095388
• Catalog Number: 66095388
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J014660953880 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220605

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: 2
• Public Version Date: 2024-10-30
• Device Publish Date: 2022-12-01

Devices Manufactured by Kulzer GmbH

• J014660874240 - dima Print Teeth & Temp: 2025-02-05 dima Print Teeth & Temp A2/B2 1000g
• J014660874260 - dima Print Teeth & Temp: 2025-02-05 dima Print Teeth & Temp A3/A3.5 1000g
• J014660874280 - dima Print Teeth & Temp: 2025-02-05 dima Print Teeth & Temp BL 1000g
• J014660874300 - dima Print Teeth & Temp: 2025-02-05 dima Print Teeth & Temp A1/B1 1000g
• 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