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The Tracker / September 2026 / K262983

510(k) cleared

EsTemp Implant

Spident Co., Ltd. · Sep 25, 2026 · K262983

FDA cleared the EsTemp Implant from Spident Co., Ltd. on Sep 25, 2026 under K262983, a special 510(k). The device falls under product code EMA, Cement, Dental, regulated at 21 CFR 872.3275 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Aug 27, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Spident Co., Ltd. has 3 other decisions in the tracker over the last 12 months: K262982 (Core·it Dual), K262050 (Vioseal X), K261129 (OrthoFit).

Questions & Answers

What did FDA clear under K262983?

K262983 is the FDA 510(k) for EsTemp Implant, submitted by Spident Co., Ltd.. FDA's decision date was Sep 25, 2026, under product code EMA (Cement, Dental).

Who makes the EsTemp Implant?

Spident Co., Ltd., based in Incheon, is the applicant of record for K262983.

How long did the K262983 review take?

FDA received the submission on Aug 27, 2026 and issued its decision on Sep 25, 2026, 29 days later.

← All decisions in September 2026

Sources