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 Sealant, Pit And Fissure, And Conditioner
510(k) Number K161580
Device Name Premier Sealant
Applicant
Premier Dental Company Products
1710 Romano Dr.
Plymouth Meeting,  PA  19462
Applicant Contact VINCENT D'ALESSANDRO
Correspondent
Premier Dental Company Products
1710 Romano Dr.
Plymouth Meeting,  PA  19462
Correspondent Contact VINCENT D'ALESSANDRO
Regulation Number872.3765
Classification Product Code
EBC  
Date Received06/08/2016
Decision Date 10/18/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-