CERAMAGE 2374

GUDID E23523740

CERAMAGE UP AM-Y 5G

SHOFU DENTAL CORPORATION

Dental prosthesis veneer resin Dental prosthesis veneer resin Dental prosthesis veneer resin Dental prosthesis veneer resin Dental prosthesis veneer resin Dental prosthesis veneer resin Dental prosthesis veneer resin Dental prosthesis veneer resin Dental prosthesis veneer resin Dental prosthesis veneer resin Dental prosthesis veneer resin Dental prosthesis veneer resin Dental prosthesis veneer resin Dental prosthesis veneer resin Dental prosthesis veneer resin Dental prosthesis veneer resin

• Primary Device ID: E23523740
• NIH Device Record Key: 6da9946f-4c5f-4b57-b5d0-8433478cea54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CERAMAGE
• Version Model Number: 2374
• Catalog Number: 2374
• Company DUNS: 054618202
• Company Name: SHOFU DENTAL CORPORATION
• Device Count: 1
• DM Exempt: false
• 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: false
• 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)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E23523740 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162261

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: 2021-02-11
• Device Publish Date: 2021-02-03

On-Brand Devices [CERAMAGE]

• E23519920: Ceramage Oxybarrier 10ml
• E23519910: Ceramage Modelling Liquid
• E23519610: Ceramage Gum-Or
• E23519600: Ceramage Gum Dark
• E23519590: Ceramage GUML
• E23519580: Ceramage Mamelon Effect Pink
• E23519570: Ceramage Mamelon Effect Yellow
• E23519560: Ceramage Trans Effects AMV
• E23519550: Ceramage Trans Effects AMR
• E23519540: Ceramage Trans Effects AMY
• E23519530: Ceramage Trans Effects OCCLUSAL
• E23519520: Ceramage Trans Effects WE
• E23519510: Ceramage Trans Effects MI
• E23519480: Ceramage F-Gum-R
• E23519470: Ceramage F-Gum-V
• E23519460: Ceramage F-Gum-Br
• E23519430: Ceramage Gum F-W
• E23519410: Ceramage F-T-Glass
• E23519400: Ceramage Gum Trans.
• E23519390: Ceramage Cervical Trans. R
• E23519380: Ceramage Cervical Trans. B
• E23519370: Ceramage Cervical Trans. A
• E23519360: Ceramage Trans Effects Grey
• E23519350: Ceramage Trans Effects Blue Glass
• E23519340: Ceramage Trans Effects TG
• E23519330: Ceramage Trans Effects LVT
• E23519320: Ceramage Trans Effects HVT
• E23519310: Ceramage Trans Effects T
• E23519270: Ceramage Body W3B
• E23519260: Ceramage Body W2B
• E23519250: Ceramage Body W1B
• E23519240: Ceramage Body SWB
• E23519220: Ceramage Dentin F-ROOTAB
• E23519210: Ceramage Dentin F-A3B
• E23519200: Ceramage Dentin R35B
• E23519190: Ceramage Dentin R3B
• E23519180: Ceramage Dentin R2B
• E23519170: Ceramage Dentin RTAB
• E23519160: Ceramage Dentin D4B
• E23519150: Ceramage Dentin D3B
• E23519140: Ceramage Dentin D2B
• E23519130: Ceramage Dentin C4B
• E23519120: Ceramage Dentin C3B
• E23519110: Ceramage Dentin C2B
• E23519100: Ceramage Dentin C1B
• E23519090: Ceramage Dentin B4B
• E23519080: Ceramage Dentin B3B
• E23519070: Ceramage Dentin B2B
• E23519060: Ceramage Dentin B1B
• E23519050: Ceramage Dentin A4B