Atlas FDA

PLV

23 FDA 510(k) clearances · Product code

116 daysmedian time to decision
287 days90th percentile
23clearances measured

FDA profile

Official device name
Dental Stereotaxic Instrument
Device class
Class II (moderate risk)
Regulation
21 CFR 872.4120
Medical specialty
Dental
FDA definition
To facilitate dental implant placement in patients that are partially endentulous or edentulous.
Adverse events (MAUDE)
2022: 39
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Yomi S Robotic System (K252376)Neocis, Inc.2025-10-28
Yomi Robotic System (K251835)Neocis, Inc.2025-10-10
Navident (K233563)Claronav, Inc.2024-07-25
Yomi Robotic System (K231018)Neocis, Inc.2023-08-14
Navident (K210947)Claronav, Inc.2022-06-27
Yomi Robotic System with YomiPlan Go (K211466)Neocis, Inc.2022-06-14
INLIANT Surgical Navigation System (K213392)Navigate Surgical Technologies, Inc.2022-02-22
Neocis Guidance System (NGS) with Yomi Plan v2.0.1 (K210711)Neocis, Inc.2021-12-22
Neocis Guidance System (NGS) with Intraoral Fiducial Array (K211129)Neocis, Inc.2021-07-28
Neocis Guidance System (NGS) with Patient Splints (EPS) (K203401)Neocis, Inc.2020-12-15
Neocis Guidance System (NGS) with Yomi Plan v2.0 (K202264)Neocis, Inc.2020-12-04
Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) (K202100)Neocis, Inc.2020-10-19
Neocis Guidance System (NGS) with Patient Splints (K200805)Neocis, Inc.2020-07-28
X-Guide® Surgical Navigation System (K200662)X-Nav Technologies, LLC2020-05-21
Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) (K200348)Neocis, Inc.2020-05-08
X-Guide Surgical Navigation System (K192579)X-Nav Technologies, LLC2020-02-03
Neocis Planning Software Application (NPSA) for 3rd Party PCs (K191363)Neocis, Inc.2019-10-02
Neocis Guidance System (NGS) (K191605)Neocis, Inc.2019-09-11
Neocis Guidance System (K182776)Neocis, Inc.2018-12-21
Neocis Guidance System (NGS) with Chairside Splint (K173402)Neocis, Inc.2018-02-22
Neocis Guidance System (K161399)Neocis, Inc.2016-12-22
Navident (K161406)Claronav, Inc.2016-09-08
X-Guide Surgical Navigation System (K150222)X-Nav Technologies, LLC2015-10-08

Track PLV automatically

Every clearance here is in the API, with alerts when new ones post.