MEDIUMRegulatoryTier 1
FDA 510(k) K261514: Calcium Hydroxide Temporary Filling Material (KP-Cal)
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 generic calcium-hydroxide root-canal filling material has cleared FDA 510(k) clearance, giving U.S. practices and DSOs another low-cost option for temporary endodontic dressings.
Key points
- Clearance K261514: Guilin Kevin Peter Technology Co., Ltd. product KP-Cal deemed substantially equivalent to predicate devices under 21 CFR 872.3820.
- Device class 2, product code KIF (resin-based root-canal filling material), usable for temporary pulp-capping and intracanal medication.
- Generic market entry may lower unit cost for temporary filling materials; owners and procurement teams should compare pricing vs. existing brands.
- No novel clinical data or indication changes; standard 510(k) clearance, not a breakthrough device.
Who should care
OwnerSpecialistStaff
Read the original on openFDA Dental Devices
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