Invisible Orthodontic Appliance

GUDID 06970402670504

SHANDONG HUGE DENTAL MATERIAL CORPORATION

Orthodontic appliance system, progressive

• Primary Device ID: 06970402670504
• NIH Device Record Key: baddb640-bd5f-428d-bfb6-d578a2921016
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invisible Orthodontic Appliance
• Version Model Number: LX-A
• 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: true
• 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	06970402670504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181747

FDA Product Code

• NXC: Aligner, Sequential

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: 2019-07-22
• Device Publish Date: 2019-07-12

Devices Manufactured by SHANDONG HUGE DENTAL MATERIAL CORPORATION

• 06970402670283 - Casting Wax: 2021-11-01
• 06970402670290 - Casting Wax: 2021-11-01
• 06970402676582 - Synthetic Polymer Teeth: 2021-11-01
• 06970402676599 - Synthetic Polymer Teeth: 2021-11-01
• 06970402676605 - Synthetic Polymer Teeth: 2021-11-01
• 06970402676612 - Synthetic Polymer Teeth: 2021-11-01
• 06970402676629 - Synthetic Polymer Teeth: 2021-11-01
• 06970402676636 - Synthetic Polymer Teeth: 2021-11-01