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 K233152
Device Name GENIOVA aligners
Applicant
Geniova Technologies Sociedad Limitada
Calle Valentin Beato 21, Planta-1
Madrid,  ES 28037
Applicant Contact Antonio Baselga de la Vega
Correspondent
Compliance4Devices
118 W Prive Cr.
118 W Prive Cr.,  FL  33445
Correspondent Contact Juan Tezak
Regulation Number872.5470
Classification Product Code
NXC  
Date Received09/27/2023
Decision Date 12/12/2024
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
-
-