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 Oral Wound Dressing
510(k) Number K252425
Device Name Silatrix Oral Gel
Applicant
Sa3, LLC
2317 Cotner Ave.
Los Angeles,  CA  90064
Applicant Contact Farbod Melamed
Correspondent
Eliquent Life Sciences, Inc.
1055 Thomas Jefferson St., Suite 450
Washington,  DC  20007
Correspondent Contact Mark Kramer
Classification Product Code
OLR  
Date Received08/01/2025
Decision Date 10/23/2025
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-