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 Material, Tooth Shade, Resin
510(k) Number K231142
Device Name Temporis, Irix Plus
Applicant
Dws S.R.L.
Via Della Meccanica 21
Thiene,  IT 36016
Applicant Contact Anna De Maria
Correspondent
Dws S.R.L.
Via Della Meccanica 21
Thiene,  IT 36016
Correspondent Contact Anna De Maria
Regulation Number872.3690
Classification Product Code
EBF  
Subsequent Product Code
EBG  
Date Received04/21/2023
Decision Date 04/25/2024
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
-
-