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FDA 510(k)

Calcium Hydroxide Temporary Filling Material (KP-Cal)

K-Number: K261514 · 2026-08-25

ApplicantGuilin Kevin Peter Technology Co., Ltd.
Decision Date2026-08-25
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Calcium Hydroxide Temporary Filling Material (KP-Cal) is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Kevin Peter Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-08-25 under 510(k) number K261514. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Calcium Hydroxide Temporary Filling Material (KP-Cal)?

Calcium Hydroxide Temporary Filling Material (KP-Cal) is a medical device that received FDA 510(k) clearance on 2026-08-25. The listed applicant is Guilin Kevin Peter Technology Co., Ltd.. The 510(k) number is K261514.

When did Calcium Hydroxide Temporary Filling Material (KP-Cal) receive FDA 510(k) clearance?

Calcium Hydroxide Temporary Filling Material (KP-Cal) received FDA 510(k) clearance on 2026-08-25, under 510(k) number K261514.

Who is the listed applicant for Calcium Hydroxide Temporary Filling Material (KP-Cal)?

The FDA 510(k) record lists Guilin Kevin Peter Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Calcium Hydroxide Temporary Filling Material (KP-Cal)?

The FDA product code for Calcium Hydroxide Temporary Filling Material (KP-Cal) is KIF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06256601Clinical Investigation of Effectiveness of a Calcium Silicate CementCOMPLETEDNCT07702942Comparative Evaluation of NeoPUTTY and MTA Pulpotomy in Mature Permanent Molars With Irreversible PulpitisCOMPLETEDNCT07703176Clinical and Radiographic Assessment of First Permanent Molars With Cention-NRECRUITING

Other records listing Guilin Kevin Peter Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261415Injectable Root Canal Sealer (KP-Root SP)

Related Devices (Code: KIF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr CorporationK251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.K252285Well-Root PTVericom Co., Ltd.K251884One-Fil Putty InjectableMediclus Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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