510(k) · Cleared
ClearedNeocis Guidance System (NGS) with Patient Splints (EPS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neocis, Inc. · PLV Dental Stereotaxic Instrument
Cleared on Dec 15, 2020 as substantially equivalent to K200805 (Neocis, Inc., 2020) after a 26-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Dec 15, 2020
- Review
- 26 days
- Class
- Class II
- Product code
- PLV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K983831 (1999). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 3 generations backK023424 Igi-SystemDenx Advanced Dental Systems · 2003
- 2 generations backK150222 X-Guide Surgical Navigation SystemX-Nav Technologies, LLC · 2015 · Recalled
- 1 generation backK200805 Neocis Guidance System (NGS) with Patient SplintsNeocis, Inc. · 2020
- This deviceK203401 Neocis Guidance System (NGS) with Patient Splints (EPS)Neocis, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −3 | K023424 | Igi-System | Denx Advanced Dental Systems | 2003 | — |
| −2 | K150222 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | 2015 | 1 |
| −1 | K200805 | Neocis Guidance System (NGS) with Patient Splints | Neocis, Inc. | 2020 | — |
| 0 (this device) | K203401 | Neocis Guidance System (NGS) with Patient Splints (EPS) | Neocis, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PLV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PLV device
- #1 K231018 Yomi Robotic Systemscore 13.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K200805 | Neocis Guidance System (NGS) with Patient SplintsSummary page 4…20) Classification: Class II Product Code: PLV III. Predicate Devices • Neocis Guidance System (NGS) with Patient Splints (K200805) IV. Indications for Use The Neocis Guidance System (NGS) is a computerized navigational system intended to provide a… | 2020 |
| † | K190059 | CEREC Guides | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All PLV devicesPLV Dental Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · PLV
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PLV
399in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PLV
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PLV
6in 2025
MAUDE reports naming product code PLV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 2 | — | 1 | 3 |
| 2020 | 7 | 86 | 1 | 0 |
| 2021 | 2 | — | 0 | 11 |
| 2022 | 3 | 399 | 0 | 39 |
| 2023 | 1 | — | 0 | 15 |
| 2024 | 1 | — | 0 | 9 |
| 2025 | 2 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. The NGS is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203401 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203401: Neocis Guidance System (NGS) with Patient Splints (EPS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203401
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026