PMMA BLOCK 11*1/BOX

GUDID 06970402677152

SHANDONG HUGE DENTAL MATERIAL CORPORATION

Temporary dental crown/bridge

• Primary Device ID: 06970402677152
• NIH Device Record Key: 61c2d8d0-9c2c-45c1-b61c-0763409155f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PMMA BLOCK
• Version Model Number: Monolayer
• Catalog Number: 11*1/BOX
• 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: true
• 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	06970402677152 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201683

FDA Product Code

• MQC: Mouthguard, Prescription

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: 2021-11-01
• Device Publish Date: 2021-10-22

On-Brand Devices [PMMA BLOCK]

• 06970402677527: Clear
• 06970402677510: Clear
• 06970402677503: Clear
• 06970402677497: Clear
• 06970402677480: Clear
• 06970402677473: Clear
• 06970402677466: Clear
• 06970402677459: Clear
• 06970402677442: Clear
• 06970402677435: Clear
• 06970402677428: Clear
• 06970402677411: Clear
• 06970402677404: Clear
• 06970402677398: Clear
• 06970402677381: Clear
• 06970402677374: Clear
• 06970402677367: Multilayer
• 06970402677350: Multilayer
• 06970402677343: Multilayer
• 06970402677336: Multilayer
• 06970402677329: Multilayer
• 06970402677312: Multilayer
• 06970402677305: Multilayer
• 06970402677299: Multilayer
• 06970402677282: Multilayer
• 06970402677275: Multilayer
• 06970402677268: Multilayer
• 06970402677251: Multilayer
• 06970402677244: Multilayer
• 06970402677237: Multilayer
• 06970402677220: Multilayer
• 06970402677213: Multilayer
• 06970402677206: Monolayer
• 06970402677190: Monolayer
• 06970402677183: Monolayer
• 06970402677176: Monolayer
• 06970402677169: Monolayer
• 06970402677152: Monolayer
• 06970402677145: Monolayer
• 06970402677138: Monolayer
• 06970402677121: Monolayer
• 06970402677114: Monolayer
• 06970402677107: Monolayer
• 06970402677091: Monolayer
• 06970402677084: Monolayer
• 06970402677077: Monolayer
• 06970402677060: Monolayer
• 06970402677053: Monolayer