GlasIonomer FX-II 3271

GUDID E23532710

Glasionomer FX-II A3 Cement

SHOFU DENTAL CORPORATION

Glass ionomer dental cement

• Primary Device ID: E23532710
• NIH Device Record Key: e198409c-7a1c-408e-8337-65095f92a87d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GlasIonomer FX-II
• Version Model Number: 3271
• Catalog Number: 3271
• Company DUNS: 054618202
• Company Name: SHOFU DENTAL CORPORATION
• Device Count: 50
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E23532710 [Primary]
HIBCC	E235327101 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031467

FDA Product Code

• EMA: Cement, Dental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

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