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 K994037
Device Name THE 4.5MM DIAMETER BICON DENTAL IMPLANT
Applicant
Bicon, Inc.
1153 Centre St., Suite 21
Boston,  MA  02130
Applicant Contact VINCENT J MORGAN
Correspondent
Bicon, Inc.
1153 Centre St., Suite 21
Boston,  MA  02130
Correspondent Contact VINCENT J MORGAN
Regulation Number872.3640
Classification Product Code
DZE  
Date Received11/29/1999
Decision Date 01/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-