• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Device Classification Name aligner, sequential
510(k) Number K192767
Device Name Clear Aligner
Royal Dental Lab
F/1, 2, 3, 5, 6, Building 2, No. 4 West Area, Shangxue
Industry Park, Bantian, Lon
Shenzhen,  CN 518129
Applicant Contact Mo Yuyun
Feiying Drug & Medical Consulting Technical Service Group
B-3F-3005, Bldg I, Southward Ruifeng Business Center, No.22
Guimiao Rd.
Shenzhen,  CN 518000
Correspondent Contact Becky Chen
Regulation Number872.5470
Classification Product Code
Date Received09/30/2019
Decision Date 01/08/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No