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 K202857
Device Name ClearPath Aligner
Applicant
ClearPath Orthodontics Ltd
6-N, Main Boulevard
Johar Town,  PK 54000
Applicant Contact Waqas Wahab
Correspondent
Qserve Group US, Inc.
7949 Beaumont Green East Drive
Indianapolis,  IN  46250
Correspondent Contact Patsy J Trisler
Regulation Number872.5470
Classification Product Code
NXC  
Date Received09/28/2020
Decision Date 01/05/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-