PacTemp Automix NE— 510(k) K261937

Name: FDA 510(k) clearance K261937
Creator: U.S. Food and Drug Administration
Published: 2026-08-07

Substantially Equivalent

The Belport Company Inc., DBA Gingi-Pak

FDA 510(k) clearance K261937 for PacTemp Automix NE, Substantially Equivalent on 2026-08-07. Applicant: The Belport Company Inc., DBA Gingi-Pak. Device class: 2.

Clearance details

Applicant: The Belport Company Inc., DBA Gingi-Pak
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2026-06-10
Decision date: 2026-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camarillo, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.