GlasIonomer FX-II FXIICSA3

GUDID E235FXIICSA30

FX-II A3 Cement Capsule Sample Kit. Contains DI's: E23532710

SHOFU DENTAL CORPORATION

Glass ionomer dental cement

• Primary Device ID: E235FXIICSA30
• NIH Device Record Key: afe2f0ed-95a3-4cd3-a1c4-103f592283d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GlasIonomer FX-II
• Version Model Number: 001
• Catalog Number: FXIICSA3
• Company DUNS: 054618202
• Company Name: SHOFU DENTAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E235FXIICSA30 [Primary]

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: 2018-09-10
• Device Publish Date: 2018-08-09

On-Brand Devices [GlasIonomer FX-II]

• E235FXIICSA30: FX-II A3 Cement Capsule Sample Kit. Contains DI's: E23532710
• E235FXIICSA20: FX-II A2 Cement Capsule Sample Kit. Contains DI's: E23532700
• E23532730: Glasionomer FX-II B2 Cement
• E23532720: Glasionomer FX-II A3.5 Cement
• E23532710: Glasionomer FX-II A3 Cement
• E23532700: Glasionomer FX-II A2 Cement