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 screw, fixation, intraosseous
510(k) Number K100182
Device Name SALVIN DENTAL SPECIALTIES FIXATION SCREW
Applicant
SALVIN DENTAL SPECIALTIES, INC.
3450 LATROBE DR.
CHARLOTTE,  NC  28211
Applicant Contact ROBERT SALVIN
Correspondent
SALVIN DENTAL SPECIALTIES, INC.
3450 LATROBE DR.
CHARLOTTE,  NC  28211
Correspondent Contact ROBERT SALVIN
Regulation Number872.4880
Classification Product Code
DZL  
Date Received01/21/2010
Decision Date 05/10/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-