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 abutment, implant, dental, endosseous
510(k) Number K162021
Device Name 3.0 Dynamic TiBase
Applicant
TALLADIUM ESPANA, SL
PLAZA UTXESA 7
LLEIDA,  ES 25002
Applicant Contact ESTEBAN XAM-MAR
Correspondent
LUIZ GALDINO
28102 Alton Way
Castaic,  CA  91384
Correspondent Contact Luiz Galdino
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/21/2016
Decision Date 05/04/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-