Venus Pearl 66098276

GUDID J014660982760

PROC Venus Pearl Kit 2x20X0.2G PLT

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: J014660982760
• NIH Device Record Key: 084f32d2-8354-42e1-acb2-4dc9fe9e2915
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venus Pearl
• Version Model Number: 66098276
• Catalog Number: 66098276
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J014660982760 [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