Glass Ionomer Cement (Luting) Powder: 10g; Liquid: 10g

GUDID 06970402670276

SHANDONG HUGE DENTAL MATERIAL CORPORATION

Glass ionomer dental cement

• Primary Device ID: 06970402670276
• NIH Device Record Key: 0a9dafd1-0e1e-45f1-8a99-6cda9ca3be0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glass Ionomer Cement (Luting)
• Version Model Number: Luting I, Luting II
• Catalog Number: Powder: 10g; Liquid: 10g
• 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	06970402670276 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161851

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 (Luting)]

• 06970402670276: Luting I, Luting II
• 06970402670252: Luting I, Luting II