K261937

PacTemp Automix NE

510(k) number
K261937
Device name
PacTemp Automix NE
Applicant
The Belport Company Inc., DBA Gingi-Pak CA · US
Product code
EMA — Cement, Dental
Decision date
2026-08-07
Date received
2026-06-10
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K261937.pdf

Official FDA record: K261937
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.