Venus Diamond 66081843

GUDID J014660818430

Venus Diamond ONE Kit-PLT

Heraeus Kulzer GmbH

Dental composite resin

• Primary Device ID: J014660818430
• NIH Device Record Key: 7e61965f-9c08-4252-bbe3-e499bc92a48c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venus Diamond
• Version Model Number: 66081843
• Catalog Number: 66081843
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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
• 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
• 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	J014660818430 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073554

FDA Product Code

• EBF: MATERIAL, TOOTH SHADE, RESIN

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-30
• Device Publish Date: 2020-03-20

On-Brand Devices [Venus Diamond]

• J014660818490: Venus Diamond PLT Sample Kit ONE
• J014660818480: Venus Diamond Syringe Sample Kit ONE
• J014660818430: Venus Diamond ONE Kit-PLT
• J014660818420: Venus Diamond ONE Kit-Syringe
• J014660818391: Venus Diamond PLT Refill 20x0.25G ONE
• J014660818381: Venus Diamond Syring Refill 1X4G ONE
• J014660968750: VENUS DIAMOND SYRINGE REFILL 1x4G BLEACH
• J014660968740: VENUS DIAMOND SYRINGE REFILL 1x4G DARK
• J014660968730: VENUS DIAMOND SYRINGE REFILL 1x4G MEDIUM
• J014660968720: VENUS DIAMOND SYRINGE REFILL 1x4G LIGHT
• J014660968710: VENUS DIAMOND PLT REFILL, 20x0, 25G BLEACH
• J014660968700: VENUS DIAMOND PLT REFILL, 20x0, 25G DARK
• J014660968690: VENUS DIAMOND PLT REFILL, 20x0, 25G MEDIUM
• J014660968680: VENUS DIAMOND PLT REFILL, 20x0, 25G LIGHT
• J014660982650: VENUS DIAMOND PURE KIT - SYRINGE
• J014660982640: VENUS DIAMOND PURE KIT - PLT
• J014660982610: VENUS DIAMOND SYRINGE SAMPLE KIT MEDIUM
• J014660982600: VENUS DIAMOND PLT SAMPLE KIT MEDIUM
• J014660982770: PROC Venus Diamond Kit 2x4G SYR
• J014660982750: PROC Venus Diamond Kit 2x20X0.25G PLT
• J014660390230: VENUS DIAMOND PLT REFILL 2x10x0,25G OD
• J014660390220: VENUS DIAMOND PLT REFILL 2x10x0,25G OM
• J014660390210: VENUS DIAMOND PLT REFILL 1x10x0,25G OL
• J014660354860: VENUS DIAMOND SYRINGE REFILL 1x4G OD
• J014660354850: VENUS DIAMOND SYRINGE REFILL 1x4G OM
• J014660354840: VENUS DIAMOND SYRINGE REFILL 1x4G OL