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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / November 2025 / K251129

510(k) cleared

S.I.N. Tapered Pro Conical Zygoma Implant System

S.I.N. Implant System Ltda · Nov 7, 2025 · K251129

FDA cleared the S.I.N. Tapered Pro Conical Zygoma Implant System from S.I.N. Implant System Ltda on Nov 7, 2025 under K251129, a traditional 510(k). The device falls under product code DZE, Implant, Endosseous, Root-Form, regulated at 21 CFR 872.3640 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Apr 11, 2025. The decision came 210 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for S.I.N. Implant System Ltda in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251129?

K251129 is the FDA 510(k) for S.I.N. Tapered Pro Conical Zygoma Implant System, submitted by S.I.N. Implant System Ltda. FDA's decision date was Nov 7, 2025, under product code DZE (Implant, Endosseous, Root-Form).

Who makes the S.I.N. Tapered Pro Conical Zygoma Implant System?

S.I.N. Implant System Ltda, based in São Paulo, is the applicant of record for K251129.

How long did the K251129 review take?

FDA received the submission on Apr 11, 2025 and issued its decision on Nov 7, 2025, 210 days later.

← All decisions in November 2025