Clear Aligner

Aligner, Sequential

Royal Dental Lab

The following data is part of a premarket notification filed by Royal Dental Lab with the FDA for Clear Aligner.

Pre-market Notification Details

• Device ID: K192767
• 510k Number: K192767
• Device Name: Clear Aligner
• Classification: Aligner, Sequential
• Applicant: Royal Dental Lab F/1, 2, 3, 5, 6, Building 2, No. 4 West Area, Shangxue Industry Park, Bantian, Lon Shenzhen, CN 518129
• Contact: Mo Yuyun
• Correspondent: Becky Chen; Feiying Drug & Medical Consulting Technical Service Group B-3F-3005, Bldg I, Southward Ruifeng Business Center, No.22 Guimiao Rd. Shenzhen, CN 518000
• Product Code: NXC
• CFR Regulation Number: 872.5470 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-09-30
• Decision Date: 2020-01-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06973051080014	K192767	000