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 K955619
Device Name 5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS
Applicant
Calcitek, Inc.
2320 Faraday Ave.
Carlsbad,  CA  92008
Applicant Contact DONNA K HOWARD
Correspondent
Calcitek, Inc.
2320 Faraday Ave.
Carlsbad,  CA  92008
Correspondent Contact DONNA K HOWARD
Regulation Number872.3640
Classification Product Code
DZE  
Date Received12/11/1995
Decision Date 03/08/1996
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
-
-