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 K103194
Device Name INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM
Applicant
Intra-Lock International, Inc.
6560 W. Rogers Cir.
Boca Raton,  FL  33487
Applicant Contact ANGELA BLACKWELL
Correspondent
Intra-Lock International, Inc.
6560 W. Rogers Cir.
Boca Raton,  FL  33487
Correspondent Contact ANGELA BLACKWELL
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received10/29/2010
Decision Date 04/21/2011
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
-
-