PLV · Dental Stereotaxic Instrument · Chrysalis Intelligence

Device class

Class II

Regulation 872.4120

Total clearances

2020-02-03 → 2025-10-28

Last 12 months

Unique sponsors

Definition

What is Dental Stereotaxic Instrument

To facilitate dental implant placement in patients that are partially endentulous or edentulous.

Classification details

Medical specialty

Dental

Review panel

Regulation number

872.4120

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Neocis, Inc.	11	2	2025-10-28
X-Nav Technologies, LLC	2	0	2020-05-21
Claronav, Inc.	2	0	2024-07-25
Navigate Surgical Technologies, Inc.	1	0	2022-02-22

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
21082	CPT	—	Medium	Dental implant abutment delivery/placement; stereotaxic guidance for implant positioning
D6010	HCPCS	—	Medium	Surgical placement of implant body; dental stereotaxic aid for placement precision

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2025-10-28	K252376	Neocis, Inc.	Yomi S Robotic System
2025-10-10	K251835	Neocis, Inc.	Yomi Robotic System
2024-07-25	K233563	Claronav, Inc.	Navident
2023-08-14	K231018	Neocis, Inc.	Yomi Robotic System
2022-06-27	K210947	Claronav, Inc.	Navident
2022-06-14	K211466	Neocis, Inc.	Yomi Robotic System with YomiPlan Go
2022-02-22	K213392	Navigate Surgical Technologies, Inc.	INLIANT Surgical Navigation System
2021-12-22	K210711	Neocis, Inc.	Neocis Guidance System (NGS) with Yomi Plan v2.0.1
2021-07-28	K211129	Neocis, Inc.	Neocis Guidance System (NGS) with Intraoral Fiducial Array
2020-12-15	K203401	Neocis, Inc.	Neocis Guidance System (NGS) with Patient Splints (EPS)
2020-12-04	K202264	Neocis, Inc.	Neocis Guidance System (NGS) with Yomi Plan v2.0
2020-10-19	K202100	Neocis, Inc.	Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)
2020-07-28	K200805	Neocis, Inc.	Neocis Guidance System (NGS) with Patient Splints
2020-05-21	K200662	X-Nav Technologies, LLC	X-Guide® Surgical Navigation System
2020-05-08	K200348	Neocis, Inc.	Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)
2020-02-03	K192579	X-Nav Technologies, LLC	X-Guide Surgical Navigation System