Venus Diamond 66098261

GUDID J014660982610

VENUS DIAMOND SYRINGE SAMPLE KIT MEDIUM

Heraeus Kulzer GmbH

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: J014660982610
• NIH Device Record Key: 35aec9ce-3ad3-4e73-8b6f-554aa2914a21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venus Diamond
• Version Model Number: 66098261
• Catalog Number: 66098261
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J014660982610 [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: 2023-12-12
• Device Publish Date: 2023-12-04

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