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 K223141
Device Name STR8 Clear Aligner
Applicant
STR8 Oral Care
217 E Cherry Ave
Jonesboro,  AR  72401
Applicant Contact Misee Harris
Correspondent
Prime Path Medtech
1321 Upland Dr.
Suite 6792
Houston,  TX  77043
Correspondent Contact Elisabeth Miller
Regulation Number872.5470
Classification Product Code
NXC  
Date Received10/04/2022
Decision Date 04/24/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-