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The Tracker / October 2026 / K262433

510(k) cleared

OrthoFit Aligner (OrthoFit Aligner A2)

Spident Co., Ltd. · Oct 13, 2026 · K262433

FDA cleared the OrthoFit Aligner (OrthoFit Aligner A2) from Spident Co., Ltd. on Oct 13, 2026 under K262433, a traditional 510(k). The device falls under product code DYH, Adhesive, Bracket And Tooth Conditioner, Resin, regulated at 21 CFR 872.3750 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jul 16, 2026. The decision came 89 days later, inside the 90 FDA-day goal for a 510(k).

Spident Co., Ltd. has 4 other decisions in the tracker over the last 12 months: K262983 (EsTemp Implant), K262982 (Core·it Dual), K262050 (Vioseal X), K261129 (OrthoFit).

Questions & Answers

What did FDA clear under K262433?

K262433 is the FDA 510(k) for OrthoFit Aligner (OrthoFit Aligner A2), submitted by Spident Co., Ltd.. FDA's decision date was Oct 13, 2026, under product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin).

Who makes the OrthoFit Aligner (OrthoFit Aligner A2)?

Spident Co., Ltd., based in Incheon, is the applicant of record for K262433.

How long did the K262433 review take?

FDA received the submission on Jul 16, 2026 and issued its decision on Oct 13, 2026, 89 days later.

← All decisions in October 2026

Sources