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 Cement, Dental
510(k) Number K261937
Device Name PacTemp Automix NE
Applicant
The Belport Company Inc., DBA Gingi-Pak
4825 Calle Alto
Camarillo,  CA  93012
Applicant Contact Nikki Huynh
Correspondent
The Belport Company Inc., DBA Gingi-Pak
4825 Calle Alto
Camarillo,  CA  93012
Correspondent Contact Nikki Huynh
Regulation Number872.3275
Classification Product Code
EMA  
Date Received06/10/2026
Decision Date 08/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-