Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 K231884
Device Name TRIOCLEAR System
Applicant
Modern Dental Laboratory (DG) Co., Ltd.
Room 102&1102 & Floor 4-10, Block 1 Modern Dental Industrial
Park, No.7 Nantou, Songshan Lake Hi-Tech Industrial Zone
Dongguan,  CN 523000
Applicant Contact Robin Liu
Correspondent
Modern Dental Laboratory Co., Ltd.
Block 1 Modern Dental Industrial Park No.7 Nantou,
Songshan Lake Hi-Tech Industrial Zone
Dongguan,  CN 523000
Correspondent Contact Robin Liu
Regulation Number872.5470
Classification Product Code
NXC  
Date Received06/27/2023
Decision Date 09/01/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-