Charisma ABC 66064793

GUDID J014660647930

Charisma ABC PLT Refill 20 x 0,2G-A3,5

Heraeus Kulzer GmbH

Dental composite resin

• Primary Device ID: J014660647930
• NIH Device Record Key: a93e149c-a8a5-41aa-9698-9d528b34c89e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Charisma ABC
• Version Model Number: 66064793
• Catalog Number: 66064793
• 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
• 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	J014660647930 [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