510(k) · Cleared
ClearedNeoss Various Titanium Abutments
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 19, 2007 as substantially equivalent to K974738 (Astra Tech, Inc., 1998) and 3 other predicates after a 106-day review. Its family tree reaches back 3 generations to 1989. 74 later devices descend from it.
- Decided
- Oct 19, 2007
- Review
- 106 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K891615 (1989). 10 ancestors in all. 74 later devices descend from it, 3 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 deviceK071838 Neoss Various Titanium AbutmentsNeoss, Ltd. · 2007
- Descendant · cites it directly · 45 of its ownK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 36 of its ownK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
- Descendant · cites it directly · 30 of its ownK103291 Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011
- Descendant · 2 generations on · 29 of its ownK122295 Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L. · 2013
- Descendant · 3 generations on · 26 of its ownK151621 BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc. · 2016
Showing 5 of 74 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 74 · See all- K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · cites it directly45descendants
- K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012 · 2 generations on36descendants
- K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011 · cites it directly30descendants
- K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L. · 2013 · 2 generations on29descendants
- K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc. · 2016 · 3 generations on26descendants
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) | K071838 | Neoss Various Titanium Abutments | Neoss, Ltd. | 2007 | — |
| +1 | K103691 | Biohorizons Abutments for Zimmer | BioHorizons Implant Systems, Inc. | 2011 | 1 |
| +2 | K112440 | AB Dental Devices Implants and Accessories | A.B. Dental Devices, Ltd. | 2012 | — |
| +1 | K103291 | Biohorizons Laser-Lok Abutments for Nobel Biocare | BioHorizons Implant Systems, Inc. | 2011 | — |
| +2 | K122295 | Core 3D Abutment System for Digital Prosthetic Solutions | Core 3D Protech, S.L. | 2013 | — |
| +3 | K151621 | BioHorizons CAD/CAM Abutments | BioHorizons Implant Systems, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 6 | 0 |
| 2022 | 9 | 0 |
| 2023 | 7 | 0 |
| 2024 | 7 | 0 |
| 2025 | 9 | 0 |
| 2026 | 5 | 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? (4)
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 |
|---|---|---|---|
| * | K974738 | Astra Tech Implant Dental SystemSummary page 1…butment system, Neoss Ltd believes the Neoss Titanium Prepable Abutment 15°and 200 is substantially equivalent to the Angulated Abutment previously cleared in K974738 and to the abutment connection in the Neoss Abutments previously cleared in K043 195. The Neoss Express Abutment is su… | 1998 |
| * | K043195 | Neo Implant SystemSummary page 1…is substantially equivalent to the Angulated Abutment previously cleared in K974738 and to the abutment connection in the Neoss Abutments previously cleared in K043 195. The Neoss Express Abutment is substantially equivalent to the Neoss Abutments previously cleared in K043195. Th… | 2005 |
| * | K994257 | Locator Implant AnchorSummary page 1…previously cleared in K043195. The Neoss Locator Abutment system is substantially equivalent to Zest Anchors Inc. Locator components initially cleared in K994257 by Zest Ancors Inc and also in K012911 submitted by Implant Innovations Inc. The accessories are equal to Neoss previo… | 2000 |
| * | K012911 | 3I Locater Abutment SystemSummary page 1…The Neoss Locator Abutment system is substantially equivalent to Zest Anchors Inc. Locator components initially cleared in K994257 by Zest Ancors Inc and also in K012911 submitted by Implant Innovations Inc. The accessories are equal to Neoss previous K043195. 3. Description of the D… | 2001 |
What descends from it? (74)
See all 743 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 18 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K103691 (BioHorizons Implant Systems, Inc., 2011) has gone furthest, with 45 descendants of its own.
- 5 other devices also cite its predicate K974738.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The Neoss various Titanium Abutments are designed to be connected to the Neoss implants and intended for use as an aid in prosthetic rehabilitation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071838 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071838: Neoss Various Titanium Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071838
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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