GLASIONOMER 3193

GUDID E23531930

GLASIONOMER CEMENT FX-II 15/10 A3

SHOFU DENTAL CORPORATION

Glass ionomer dental cement

• Primary Device ID: E23531930
• NIH Device Record Key: 1ef2a75e-9d89-4eac-a5ce-0cacbc67fe57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GLASIONOMER
• Version Model Number: 3193
• Catalog Number: 3193
• 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	E23531930 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-11
• Device Publish Date: 2021-02-03

On-Brand Devices [GLASIONOMER]

• E23532050: FX-II MINI KIT (B2)
• E23532040: FX-II MINI KIT (A3.5)
• E23532030: FX-II MINI KIT (A3)
• E23532020: FX-II MINI KIT (A2)
• E23531950: GLASIONOMER CEMENT FX-II 15/10 B2
• E23531940: GLASIONOMER CEMENT FX-II 15/10 A3.5
• E23531930: GLASIONOMER CEMENT FX-II 15/10 A3
• E23531920: GLASIONOMER CEMENT FX-II 15/10 A2
• E23511870: CX-PLUS 1-1 KIT (15 GM / 8 ML)
• E23511690: G.I. CX PLUS TRIPLE KIT
• E23511680: G.I. CX PLUS LIQUID 17ML
• E23511670: G.I. CX PLUS POWDER 35G
• E23511660: G.I. CX PLUS POWDER / LIQUID
• E23511480: GLASSIONOMER TYPE V MATRIX STR