GLASIONOMER 1169

GUDID E23511690

G.I. CX PLUS TRIPLE KIT

SHOFU DENTAL CORPORATION

Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement

• Primary Device ID: E23511690
• NIH Device Record Key: e3bd90bd-9394-4041-ae1c-63f2f565d1ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GLASIONOMER
• Version Model Number: 1169
• Catalog Number: 1169
• 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	E23511690 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982461

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