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 K233625
Device Name RAYDENT SW
Applicant
RAY Co., Ltd.
1F~3F, 4F(Part), 5F, 265, Daeji-Ro, Suji-gu
Yongin-si,  KR 16882
Applicant Contact Huh Soo Ji
Correspondent
RAY Co., Ltd.
1F~3F, 4F(Part), 5F, 265, Daeji-Ro, Suji-gu
Yongin-si,  KR 16882
Correspondent Contact Huh Soo Ji
Regulation Number872.5470
Classification Product Code
PNN  
Subsequent Product Code
NOF  
Date Received11/13/2023
Decision Date 05/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-