Ceramage 1837

GUDID E23518370

Ceramage Opaque ROOTAO

SHOFU DENTAL CORPORATION

Dental prosthesis veneer resin

• Primary Device ID: E23518370
• NIH Device Record Key: 82de0a99-0dfe-42e8-bd72-877fdc470087
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ceramage
• Version Model Number: 1837
• Catalog Number: 1837
• 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: 760-566-3528
• Email: ckaemmerlen@shofu.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E23518370 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050401

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: 2018-07-24
• Device Publish Date: 2016-09-24

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