• 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 implant, endosseous, root-form
510(k) Number K131345
Device Name TIARRAY DENTAL IMPLANT SYSTEM
Applicant
NASSEO, INC.
12264 El Camino Real, Suite 400
san diego,  CA  92130
Applicant Contact allison c komiyama
Correspondent
NASSEO, INC.
12264 El Camino Real, Suite 400
san diego,  CA  92130
Correspondent Contact allison c komiyama
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received05/09/2013
Decision Date 08/07/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-