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 K223338
Device Name Toothsi, Smilealigners
Applicant
AMPA Orthodontics Private Limited
1st Floor Empire Plaza B Wing, Lal Bahadur Shastri Marg,
Vikhroli (West)
Mumbai,  IN 400083
Applicant Contact Manjul Jain
Correspondent
Intrust
A301/A Green Heritage, Plot 79-80, Sector 20
Kharghar,  IN 410210
Correspondent Contact Sanjeev Kumar Gupta
Regulation Number872.5470
Classification Product Code
NXC  
Date Received11/01/2022
Decision Date 02/09/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-