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 K191836
Device Name Ceramill A-Splint
Applicant
Amann Girrbach AG
Herrschaftswiesen 1
Koblach,  AT 6842
Applicant Contact Debora Engel
Correspondent
Emergo Europe Consulting
Prinsessegracht 20
The Hague,  NL
Correspondent Contact Rachel Paul
Classification Product Code
MQC  
Date Received07/09/2019
Decision Date 12/20/2019
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-