CERAMAGE 2340

GUDID E23523400

CERAMAGE UP RTAB 5G

SHOFU DENTAL CORPORATION

Dental prosthesis veneer resin

• Primary Device ID: E23523400
• NIH Device Record Key: 01977fe8-a9fb-400e-9e4b-1ce6352ea8c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CERAMAGE
• Version Model Number: 2340
• Catalog Number: 2340
• 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	E23523400 [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