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 K972351
Device Name SENDAX MDI (MINI DENTAL IMPLANT)
Applicant
Sendax Mdic Management, Inc.
30 Central Park S.
Suite 4b
New York,  NY  10019
Applicant Contact VICTOR I SENDAX
Correspondent
Sendax Mdic Management, Inc.
30 Central Park S.
Suite 4b
New York,  NY  10019
Correspondent Contact VICTOR I SENDAX
Regulation Number872.3640
Classification Product Code
DZE  
Date Received06/24/1997
Decision Date 11/24/1997
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
-
-