Calcium Hydroxide Temporary Filling Material (KP-Cal)

FDA 510(k) K261514 · Guilin Kevin Peter Technology Co., Ltd.

Substantially Equivalent

510(k) numberK261514

Submission

Device name
Calcium Hydroxide Temporary Filling Material (KP-Cal)
Applicant
Guilin Kevin Peter Technology Co., Ltd.
Guilin, CN
Received
May 7, 2026
Decision date
August 25, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KIF – Resin, Root Canal Filling
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3820
Specialty
Dental

Other 510(k)s with product code KIF

510(k)DeviceApplicantDecision
K262050Vioseal XKIF · Traditional Spident Co., Ltd.09/11/2026SE
K253909NeoPEX™ Pre-Mixed Obturation PasteKIF · Traditional NuSmile, Ltd.09/04/2026SE
K261415Injectable Root Canal Sealer (KP-Root SP)KIF · Traditional Guilin Kevin Peter Technology Co., Ltd.06/29/2026SE
K253167Any-PasteKIF · Traditional Mediclus Co., Ltd.01/12/2026SE
K252890ZenSeal ProKIF · Traditional Kerr Corporation01/07/2026SE
K251465Root canal repair materials (nRoot BP)KIF · Traditional Enpuno Biotechnology Co., Ltd.09/25/2025SE
K252285Well-Root PTKIF · Traditional Vericom Co., Ltd.09/19/2025SE
K251884One-Fil Putty InjectableKIF · Special Mediclus Co., Ltd.08/22/2025SE
K251390MTA vptKIF · Traditional Voco GmbH07/03/2025SE
K250710Injectable Root Canal Bioceramic Sealer (nRoot SP)KIF · Traditional Enpuno Co., Ltd.06/11/2025SE

More from Enpuno Co., Ltd.

510(k)DeviceDecision
K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)EBF · Traditional 08/31/2026SE
K261415Injectable Root Canal Sealer (KP-Root SP)KIF · Traditional 06/29/2026SE

Questions and answers

When was Calcium Hydroxide Temporary Filling Material (KP-Cal) cleared by the FDA?

Calcium Hydroxide Temporary Filling Material (KP-Cal) (K261514) received a 510(k) decision of Substantially Equivalent on August 25, 2026, 110 days after the submission was received.

What is the product code of K261514?

The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.