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 Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner

• 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