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 K921854
Device Name IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MM
Applicant
Impla-Med
13794 NW 4th. St.,
Suite 209
Sunrise,  FL  33325
Applicant Contact WALTON, JR
Correspondent
Impla-Med
13794 NW 4th. St.,
Suite 209
Sunrise,  FL  33325
Correspondent Contact WALTON, JR
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/17/1992
Decision Date 10/27/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-