PMMA BLOCK 1*1/BOX

GUDID 06970402660482

Huge Dental Material Co., Ltd.

Dental crown/bridge, temporary

• Primary Device ID: 06970402660482
• NIH Device Record Key: b283a637-21f7-44a7-9c3f-4ef71ad29f6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PMMA BLOCK
• Version Model Number: Monolayer
• Catalog Number: 1*1/BOX
• Company DUNS: 420283541
• Company Name: Huge Dental Material Co., Ltd.
• 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	06970402660482 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141421

FDA Product Code

• EBG: Crown And Bridge, Temporary, Resin

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: 2016-09-09

On-Brand Devices [PMMA BLOCK]

• 06970402661588: Clear
• 06970402661571: Clear
• 06970402661564: Clear
• 06970402661557: Clear
• 06970402661540: Clear
• 06970402661533: Clear
• 06970402661526: Clear
• 06970402661519: Multilayer
• 06970402661502: Multilayer
• 06970402661496: Multilayer
• 06970402661489: Multilayer
• 06970402661472: Multilayer
• 06970402661465: Multilayer
• 06970402661458: Multilayer
• 06970402661441: Monolayer
• 06970402661434: Monolayer
• 06970402661427: Monolayer
• 06970402661410: Monolayer
• 06970402661403: Monolayer
• 06970402661397: Monolayer
• 06970402661380: Monolayer
• 06970402661373: Multilayer
• 06970402661366: Multilayer
• 06970402661359: Monolayer
• 06970402661342: Monolayer
• 06970402661335: Clear
• 06970402661328: Clear
• 06970402661311: Clear
• 06970402661304: Clear
• 06970402661298: Clear
• 06970402661281: Clear
• 06970402660611: Clear
• 06970402660604: Clear
• 06970402660598: Multilayer
• 06970402660581: Multilayer
• 06970402660574: Multilayer
• 06970402660567: Multilayer
• 06970402660550: Multilayer
• 06970402660543: Multilayer
• 06970402660536: Monolayer
• 06970402660529: Monolayer
• 06970402660512: Monolayer
• 06970402660505: Monolayer
• 06970402660499: Monolayer
• 06970402660482: Monolayer