MEDIUMRegulatoryTier 1
FDA 510(k) K262983: EsTemp Implant
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
Spident Co., Ltd. received FDA clearance for a new Class II dental cement (EsTemp Implant) that dental practices and DSOs can now stock as an alternative restorative material.
Key points
- Device cleared under 510(k) K262983 as substantially equivalent (Special) with product code EMA.
- Cleared under 21 CFR 872.3275 for dental cement use.
- Adds another commercially available option for restorative procedures without altering existing workflows.
- No recall or safety alert is indicated in the clearance record.
Who should care
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Read the original on openFDA Dental Devices
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