510(k) · Cleared
ClearedNeocis Guidance System (NGS) with Intraoral Fiducial Array
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 Jul 28, 2021 as substantially equivalent to K161399 (Neocis, Inc., 2016) after a 103-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Jul 28, 2021
- Review
- 103 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 backK161399 Neocis Guidance SystemNeocis, Inc. · 2016 · Recalled
- This deviceK211129 Neocis Guidance System (NGS) with Intraoral Fiducial ArrayNeocis, Inc. · 2021
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 | K161399 | Neocis Guidance System | Neocis, Inc. | 2016 | 1 |
| 0 (this device) | K211129 | Neocis Guidance System (NGS) with Intraoral Fiducial Array | Neocis, Inc. | 2021 | — |
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 |
|---|---|---|---|
| * | K161399 | Neocis Guidance SystemSummary page 4…) Classification: Class II Product Code: PLV III. Predicate Devices • Primary Predicate – • Neocis Guidance System (NGS) (K161399) • Reference Devices: • Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)… | 2016 |
| † | K202348 | External Remote Controller ERC 4P | 2020 |
| † | K202100 | Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) | 2020 |
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 22 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 2 other devices also cite its predicate K161399.
How does its category compare?
All PLV devicesPLV Dental Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211129 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211129: Neocis Guidance System (NGS) with Intraoral Fiducial Array.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211129
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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