Venus Pearl 66098278

GUDID J014660982780

PROC Venus Pearl Kit 2x3G SYR

Heraeus Kulzer GmbH

Dental composite resin

• Primary Device ID: J014660982780
• NIH Device Record Key: 544fa4ab-fd40-4ae3-9c29-998ccada41fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venus Pearl
• Version Model Number: 66098278
• Catalog Number: 66098278
• 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

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	J014660982780 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-14
• Device Publish Date: 2024-03-06

On-Brand Devices [Venus Pearl]

• J014660818470: Venus Pearl PLT Sample Kit ONE
• J014660818460: Venus Pearl Syringe Sample Kit ONE
• J014660818410: Venus Pearl One Kit-PLT
• J01466081840: Venus Pearl One Kit-Syringe
• J014660818371: Venus Pearl PLT Refill 20x0.2G ONE
• J014660818361: Venus Pearl Syring Refill 1x3G ONE
• J014660968830: VENUS PEARL SYRINGE REFILL 1x3G BLEACH
• J014660968820: VENUS PEARL SYRINGE REFILL 1x3G DARK
• J014660968810: VENUS PEARL SYRINGE REFILL 1x3G MEDIUM
• J014660968800: VENUS PEARL SYRINGE REFILL 1x3G LIGHT
• J014660968790: VENUS PEARL PLT REFILL 20x0, 2G BLEACH
• J014660968770: VENUS PEARL PLT REFILL 20x0,2G MEDIUM
• J014660968760: VENUS PEARL PLT REFILL 20x0,2G LIGHT
• J014660968670: Venus Pearl PLT Master Assortment
• J014660482010: Venus Pearl Syringe Refill 1x3G GUM
• J014660482000: Venus Pearl Syringe Refill 1x3G CORE
• J014660481970: Venus Pearl Syringe Refill 1x3G AM
• J014660481960: Venus Pearl Syringe Refill 1x3G CL
• J014660481950: Venus Pearl Syringe Refill 1x3G OB
• J014660481910: Venus Pearl Syringe Refill 1x3G ODC
• J014660481900: Venus Pearl Syringe Refill 1x3G OMC
• J014660481880: Venus Pearl Syringe Refill 1x3G D3
• J014660481860: Venus Pearl Syringe Refill 1x3G C2
• J014660481810: Venus Pearl Syringe Refill 1x3G HKA5
• J014660481790: Venus Pearl Syringe Refill 1x3G A3.5
• J014660481780: Venus Pearl Syringe Refill 1x3G A3
• J014660481760: Venus Pearl Syringe Refill 1x3G A2
• J014660481750: Venus Pearl Syringe Refill 1x3G A1
• J014660481720: Venus Pearl PLT Refill 10x0,3G CORE
• J014660481650: Venus Pearl PLT Refill 10x0,2G OMC
• J014660481640: Venus Pearl PLT Refill 10x0,2G OLC
• J014660481620: Venus Pearl PLT Refill 20x0,2G C3
• J014660481610: Venus Pearl PLT Refill 20x0,2G C2
• J014660481500: Venus Pearl PLT Refill 20x0,2G C1
• J014660481460: Venus Pearl PLT Refill 20x0,2G HKA5
• J014660481430: Venus Pearl PLT Refill 20x0,2G A3
• J014660481420: Venus Pearl PLT Refill 20x0,2G HKA2.5
• J014660481000: Venus Pearl PLT Refill 10x0,2G CO
• J014660480990: Venus Pearl PLT Refill 10x0,2G AM
• J014660480980: Venus Pearl PLT Refill 10x0,2G CL
• J014660481990: Venus Pearl Syringe Refill 1x3G YO
• J014660481980: Venus Pearl Syringe Refill 1x3G CO
• J014660481940: Venus Pearl Syringe Refill 1x3G BXL
• J014660481930: Venus Pearl Syringe Refill 1x3G BL
• J014660481920: Venus Pearl Syringe Refill 1x3G OXDC
• J014660481840: Venus Pearl Syringe Refill 1x3G B3
• J014660481830: Venus Pearl Syringe Refill 1x3G B2
• J014660481820: Venus Pearl Syringe Refill 1x3G B1
• J014660481800: Venus Pearl Syringe Refill 1x3G A4
• J014660481770: Venus Pearl Syringe Refill 1x3G HKA2.5