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 mouthguard, prescription
510(k) Number K232448
Device Name FREEPRINT® splintmaster
Applicant
Detax GmbH
Carl-Zeiss-Strasse 4
Ettingen,  DE D-76275
Applicant Contact Markus Stratmann
Correspondent
Aclivi, LLC
3250 Brackley Drive
Ann Arbor,  MI  48105
Correspondent Contact Chris Brown
Classification Product Code
MQC  
Subsequent Product Code
KMY  
Date Received08/14/2023
Decision Date 10/12/2023
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-