GlasIonomer F 1138

GUDID E23511380

GLASIONOMER VARNISH

SHOFU DENTAL CORPORATION

Dental restorative material varnish

• Primary Device ID: E23511380
• NIH Device Record Key: 8997b046-8565-4196-a7d9-0f558ddc2ea0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GlasIonomer F
• Version Model Number: 1138
• Catalog Number: 1138
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E23511380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K850913

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: 2016-09-26

On-Brand Devices [GlasIonomer F ]

• E23511440: Discountinued
• E23511430: GLAS II PWD/GRAY
• E23511420: GLAS II PWD/YLLW
• E23511410: GLAS II PWD/UNIV
• E23511400: GLAS II LIQUID
• E23511380: GLASIONOMER VARNISH
• E23511340: Discountinued
• E23511330: GLAS II KIT/1-GRAY
• E23511320: GLAS II KIT/1-YLLW
• E23511310: GLAS II KIT/1 UNIV
• E23511300: GLAS II KIT/4-COLOR