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 K021915
Device Name TRANSITIONAL IMPLANTS
Applicant
Intra-Lock International
1200 N. Federal Hwy.
Suite 200
Boca Raton,  FL  33432
Applicant Contact JEFFREY SAKOFF
Correspondent
Intra-Lock International
1200 N. Federal Hwy.
Suite 200
Boca Raton,  FL  33432
Correspondent Contact JEFFREY SAKOFF
Regulation Number872.3640
Classification Product Code
DZE  
Date Received06/11/2002
Decision Date 12/19/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-