FDA 510(k) K261937: PacTemp Automix NE
Summary & scoring by The Bell Brief (Dr. Jennifer Bell) using the Drill-Down Protocol (Drill-Down Score) — not the original publisher.
Why it matters for dental
A new 510(k) clearance for a dental cement expands the options for temporary restorations, which may influence material costs and procurement choices for general and specialty practices.
Key points
- 510(k) K261937 cleared PacTemp Automix NE, a Class II dental cement (product code EMA) manufactured by Gingi-Pak.
- Clearance issued under 21 CFR 872.3275, confirming the device is substantially equivalent to existing temporary cements.
- The product is a traditional 510(k) submission, meaning it is a me-too material rather than a novel technology.
- General and restorative dentists may add this cement to their inventory, potentially affecting supplier negotiations and inventory turnover.
Who should care
Read the original on openFDA Dental Devices
Full reporting and any paywall content live on accessdata.fda.gov. We summarize and score; we do not republish.
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