GUDID 06973051080014

This device is indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.

Royal Dental Lab

Orthodontic appliance system, progressive

• Primary Device ID: 06973051080014
• NIH Device Record Key: 2615c058-e2dd-4595-9be2-3a7189bfaa8b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: V1.0
• Company DUNS: 529128636
• Company Name: Royal Dental Lab
• 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

Customer Support Contacts

• Phone: +86075589501914
• Email: fiona@china-dental.com
• Phone: +86075589501914
• Email: fiona@china-dental.com
• Phone: +86075589501914
• Email: fiona@china-dental.com
• Phone: +86075589501914
• Email: fiona@china-dental.com
• Phone: +86075589501914
• Email: fiona@china-dental.com
• Phone: +86075589501914
• Email: fiona@china-dental.com
• Phone: +86075589501914
• Email: fiona@china-dental.com
• Phone: +86075589501914
• Email: fiona@china-dental.com
• Phone: +86075589501914
• Email: fiona@china-dental.com
• Phone: +86075589501914
• Email: fiona@china-dental.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973051080014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192767

FDA Product Code

• NXC: Aligner, Sequential

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-04-21
• Device Publish Date: 2020-02-13