Data / Medical devices / United States / Neocis Inc

Neocis Inc: FDA-registered device maker in Miami, FL, United States, 2 510(k) clearances

Name: Neocis Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Neocis Inc is registered with the FDA (registration 3012787974) in Miami, FL, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 28, 2025. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3012787974
Address: 545 NW 26th St Unit 700, Miami, FL, United States, 33127
Owner or operator: Neocis (10053750)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: December 9, 2022
Registered through: 2027
Brand names listed: Yomi Robotic System, Yomi S Robotic System

Devices it lists

Device	Product code	Class	Role	Source
Dental Navigation System	QRY	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Dental Stereotaxic Instrument	PLV	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Holder, Head, Radiographic	IWY	1	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 28, 2025	K252376	Yomi S Robotic System	PLV	Substantially Equivalent	Neocis, Inc.	accessdata.fda.gov
December 8, 2022	K222750	Yomi Robotic System	QRY	Substantially Equivalent	Neocis, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 30, 2020	87060	Class II	Terminated	DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)	The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled.	accessdata.fda.gov
May 14, 2020	85856	Class II	Terminated	DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implant	The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.	accessdata.fda.gov
October 4, 2019	84070	Class II	Terminated	Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intraope	The Fiducial Array may mismatch their measurement files resulting in failed landmark check.	accessdata.fda.gov

Compare with other makers

Updated October 28, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.