Zirconia Block

GUDID 06970402670207

SHANDONG HUGE DENTAL MATERIAL CORPORATION

Dental appliance fabrication material, ceramic

• Primary Device ID: 06970402670207
• NIH Device Record Key: a8aa4745-4885-423d-8c92-590a0ac3fe94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zirconia Block
• Version Model Number: Anterior Translucency (AT)
• 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: false
• 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	06970402670207 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141162

FDA Product Code

• EIH: Powder, Porcelain

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-24
• Device Publish Date: 2016-09-09

On-Brand Devices [Zirconia Block]

• 06970402675035: MAT
• 06970402675028: MHT
• 06970402675011: AT
• 06970402675004: HT
• 06970402674991: HS
• 06970402670306: Multi-layered High Translucency (MHT)
• 06970402670238: Multi-layered High Translucency (ML)
• 06970402670221: Super Translucency (ST)
• 06970402670207: Anterior Translucency (AT)
• 06970402670191: High Strength (HS)
• 06970402670184: High Translucency ( HT)