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 Orthodontic Software
510(k) Number K192847
Device Name AUTOLIGN
Applicant
Diorco Co., Ltd.
4F, 26 Yeongil-ro, Yeongtong-gu
Suwon-si,  KR 16705
Applicant Contact Yongkyu Jin
Correspondent
Radios LLC
4408 Tortuga Ln
McKinney,  TX  75070
Correspondent Contact Edward Park
Regulation Number872.5470
Classification Product Code
PNN  
Subsequent Product Code
LLZ  
Date Received10/03/2019
Decision Date 07/21/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-