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The Tracker / October 2026 / K262084

510(k) cleared

S.I.N. Instruments Kits

S.I.N. Implant System Ltda · Oct 22, 2026 · K262084

FDA cleared the S.I.N. Instruments Kits from S.I.N. Implant System Ltda on Oct 22, 2026 under K262084, a traditional 510(k). The device falls under product code KCT, Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, regulated at 21 CFR 880.6850 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jun 22, 2026. The decision came 122 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

S.I.N. Implant System Ltda has one other decision in the tracker over the last 12 months: K251129 (S.I.N. Tapered Pro Conical Zygoma Implant System).

Questions & Answers

What did FDA clear under K262084?

K262084 is the FDA 510(k) for S.I.N. Instruments Kits, submitted by S.I.N. Implant System Ltda. FDA's decision date was Oct 22, 2026, under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories).

Who makes the S.I.N. Instruments Kits?

S.I.N. Implant System Ltda, based in São Paulo, is the applicant of record for K262084.

How long did the K262084 review take?

FDA received the submission on Jun 22, 2026 and issued its decision on Oct 22, 2026, 122 days later.

← All decisions in October 2026

Sources