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 implant, endosseous, root-form
510(k) Number K034014
Device Name SPI CONTACT DENTAL IMPLANT
Applicant
THOMMEN MEDICAL, AG
11234 EL CAMINO REAL, STE. 200
SAN DIEGO,  CA  92130
Applicant Contact FLOYD G LARSON
Correspondent
THOMMEN MEDICAL, AG
11234 EL CAMINO REAL, STE. 200
SAN DIEGO,  CA  92130
Correspondent Contact FLOYD G LARSON
Regulation Number872.3640
Classification Product Code
DZE  
Date Received12/24/2003
Decision Date 03/05/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-