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 K180609
Device Name Rodo Smilekey
Applicant
Rodo Medical, Inc.
6399 San Ignacio Ave., Suite 100
San Jose,  CA  95119
Applicant Contact Michael Parsons
Correspondent
Hogan Lovells US LLP
555 Thirteen Street NW
Washington,  DC  20004
Correspondent Contact Randy Prebula
Regulation Number872.3630
Classification Product Code
NHA  
Date Received03/08/2018
Decision Date 05/23/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-