• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name reliner, denture, over the counter
510(k) Number K121318
Device Name PROSOFT
Original Applicant
PERMA LABORATORIES
120 wakefield run blvd
hinckley,  OH  44233
Regulation Number872.3560
Classification Product Code
EBP  
Date Received05/02/2012
Decision Date 06/06/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
-
-