Glass Ionomer Cement (Filling) Powder: 5g; Liquid: 5g

GUDID 06970402670269

SHANDONG HUGE DENTAL MATERIAL CORPORATION

Glass ionomer dental cement

• Primary Device ID: 06970402670269
• NIH Device Record Key: 683df000-af38-49da-9232-47cdd7ee3ca6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glass Ionomer Cement (Filling)
• Version Model Number: Filling I, Filling II
• Catalog Number: Powder: 5g; Liquid: 5g
• Company DUNS: 528184691
• Company Name: SHANDONG HUGE DENTAL MATERIAL 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970402670269 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160345

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: 2017-11-17

On-Brand Devices [Glass Ionomer Cement (Filling)]

• 06970402670269: Filling I, Filling II
• 06970402670245: Filling I, Filling II