Chrysalis Intelligence · Sponsors · Neocis, Inc.

Neocis, Inc.

Miami, FL, US · 13 510(k) clearances · 4 recalls

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Total clearances

13

2020-05-08 → 2025-10-28

Last 12 months

2

Product codes

2

Most recent

2025-10-28

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
PLV	Dental Stereotaxic Instrument	Class II	Dental	11	2025-10-28
QRY	Dental Navigation System	Class II	Dental	2	2022-12-08

Safety

Recalls (4)

Class I (serious)

0

Risk of injury / death

Total recalls

4

Currently ongoing

0

Most recent

2020-10-30

Date	Severity	Status	Recall #	Product	Code	Reason
2020-10-30	Class II	Terminated	Z-0929-2021	DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis …	—	The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled.
2020-05-14	Class II	Terminated	Z-2639-2020	DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistan…	—	The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
2020-05-14	Class II	Terminated	Z-2638-2020	DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assista…	—	The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
2020-05-14	Class II	Terminated	Z-2637-2020	DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assista…	—	The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.

Filings

All 510(k) clearances (13)

Date	K-number	Device	Code	Class	Specialty
2025-10-28	K252376	Yomi S Robotic System	PLV	Class II	Dental
2025-10-10	K251835	Yomi Robotic System	PLV	Class II	Dental
2023-08-14	K231018	Yomi Robotic System	PLV	Class II	Dental
2022-12-08	K222750	Yomi Robotic System	QRY	Class II	Dental
2022-11-04	K222049	Yomi Robotic System	QRY	Class II	Dental
2022-06-14	K211466	Yomi Robotic System with YomiPlan Go	PLV	Class II	Dental
2021-12-22	K210711	Neocis Guidance System (NGS) with Yomi Plan v2.0.1	PLV	Class II	Dental
2021-07-28	K211129	Neocis Guidance System (NGS) with Intraoral Fiducial Array	PLV	Class II	Dental
2020-12-15	K203401	Neocis Guidance System (NGS) with Patient Splints (EPS)	PLV	Class II	Dental
2020-12-04	K202264	Neocis Guidance System (NGS) with Yomi Plan v2.0	PLV	Class II	Dental
2020-10-19	K202100	Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)	PLV	Class II	Dental
2020-07-28	K200805	Neocis Guidance System (NGS) with Patient Splints	PLV	Class II	Dental
2020-05-08	K200348	Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)	PLV	Class II	Dental