K261937
- 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.