510(k) · Cleared
ClearedNeoss TiBase, Neoss CoCr Abutments (Mono and Multi)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neoss, Ltd. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Oct 8, 2015 as substantially equivalent to K043195 (Neoss, Ltd., 2005) after a 206-day review. Its family tree reaches back 3 generations to 1989. 14 later devices descend from it.
- Decided
- Oct 8, 2015
- Review
- 206 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K891615 (1989). 7 ancestors in all. 14 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK891615 Surgical DrillsImplant Innovations International, Inc. · 1989
- 2 generations backK962014 3I Single Use, Disposable Drills,Taps,Burs, Etc.Implant Innovations, Inc. · 1996
- 1 generation backK043195 Neo Implant SystemNeoss, Ltd. · 2005
- This deviceK150669 Neoss TiBase, Neoss CoCr Abutments (Mono and Multi)Neoss, Ltd. · 2015
- Descendant · cites it directly · 13 of its ownK163634 External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · Recalled
- Descendant · 2 generations on · 3 of its ownK193084 TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020
- Descendant · 2 generations on · 2 of its ownK183024 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020
- Descendant · 2 generations on · 2 of its ownK180465 Provata Implant SystemSouthern Implants (Pty), Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK231967 ARi ExCon Implant SystemMegagen Implant Co., Ltd. · 2023
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K163634External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · cites it directly13descendants
- K193084TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020 · 2 generations on3descendants
- K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020 · 2 generations on2descendants
- K180465Provata Implant SystemSouthern Implants (Pty), Ltd. · 2018 · 2 generations on2descendants
- K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd. · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K891615 | Surgical Drills | Implant Innovations International, Inc. | 1989 | — |
| −2 | K962014 | 3I Single Use, Disposable Drills,Taps,Burs, Etc. | Implant Innovations, Inc. | 1996 | — |
| −1 | K043195 | Neo Implant System | Neoss, Ltd. | 2005 | — |
| 0 (this device) | K150669 | Neoss TiBase, Neoss CoCr Abutments (Mono and Multi) | Neoss, Ltd. | 2015 | — |
| +1 | K163634 | External Hex Implants | Southern Implants (Pty), Ltd. | 2017 | 1 |
| +2 | K193084 | TIB Abutment System | Southern Implants (Pty), Ltd. | 2020 | — |
| +2 | K183024 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2020 | — |
| +2 | K180465 | Provata Implant System | Southern Implants (Pty), Ltd. | 2018 | — |
| +2 | K231967 | ARi ExCon Implant System | Megagen Implant Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 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 |
|---|---|---|---|
| * | K043195 | Neo Implant SystemSummary page 6…ials for the Ti Base are identical to those used for Neoss Implant System 2 components previously cleared in K043195, K071838 and K113376. The pure gold and process used to coat the titanium alloy Crystaloc screw are identical to the titanium and… | 2005 |
| † | K071838 | Neoss Various Titanium Abutments | 2007 |
| † | K113376 | Neoss Proactive Tapered Implant | 2012 |
| † | K081851 | Neoss Access Abutments | 2009 |
| † | K111421 | Sirona Dental Cad/Cam System | 2012 |
| † | K100152 | Sirona Cad/Cam System | 2010 |
| † | K083496 | Camlog Implant System Modified Implants and Abutments | 2009 |
| † | K121843 | NP-Cast Abutment System | 2012 |
What descends from it? (14)
See all 142 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 26 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K163634 (Southern Implants (Pty), Ltd., 2017) has gone furthest, with 13 descendants of its own.
- 5 other devices also cite its predicate K043195.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
Neoss Abutments are designed to be connected to the Neoss Implants and intended for use as an aid in prosthetic rehabilitation.
The Neoss TiBase is compatible with the Sirona Dental System inCoris ZI Meso L. All digitally designed copings and/or crowns for use with the Neoss TiBase Abutments are to be designed and milled using the Sirona Dental CAD/CAM System.
Neoss abutments are designed to be connected to the Neoss Implants and intended for use as an aid in prosthetic rehabilitation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150669 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150669: Neoss TiBase, Neoss CoCr Abutments (Mono and Multi).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150669
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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