Charisma ABC 66064773

GUDID J014660647730

Charisma ABC Syr Refill 1 x 4G-A2

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 Dental composite resin

• Primary Device ID: J014660647730
• NIH Device Record Key: 23bc8a8e-1621-420e-a959-59c002c32122
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Charisma ABC
• Version Model Number: 66064773
• Catalog Number: 66064773
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J014660647730 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020131

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: 4
• Public Version Date: 2023-07-14
• Device Publish Date: 2016-09-23

On-Brand Devices [Charisma ABC]

• J014660647970: Charisma ABC PLT Refill 20 x 0,2G-OPAQUE
• J014660647960: Charisma ABC PLT Refill 20 x 0,2G-C2
• J014660647950: Charisma ABC PLT Refill 20 x 0,2G-B2
• J014660647940: Charisma ABC PLT Refill 20 x 0,2G-A4
• J014660647930: Charisma ABC PLT Refill 20 x 0,2G-A3,5
• J014660647920: Charisma ABC PLT Refill 20 x 0,2G-A3
• J014660647910: Charisma ABC PLT Refill 20 x 0,2G-A2
• J014660647800: Charisma ABC PLT Refill 20 x 0,2G-A1
• J014660647790: Charisma ABC Syr Refill 20 x 0,2G-OPAQUE
• J014660647760: Charisma ABC Syr Refill 1 x 4G-A4
• J014660647740: Charisma ABC Syr Refill 1 x 4G-A3
• J014660647730: Charisma ABC Syr Refill 1 x 4G-A2
• J014660647720: Charisma ABC Syr Refill 1 x 4G-A1
• J014660647780: Charisma ABC Syr Refill 1 x4G-C2
• J014660647770: Charisma ABC Syr Refill 1 x4G-A4
• J014660647750: Charisma ABC Syr Refill 1 x4G-A3,5