510(k) · Cleared
ClearedTDS Abutment for Nobel Biocare Replace
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pou YU Biotechnology Co., Ltd. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jun 24, 2009 after a 75-day review. The FDA summary names no predicate by number. 43 later devices descend from it.
- Decided
- Jun 24, 2009
- Review
- 75 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 0
43 later devices descend from it, 4 citing it directly.
- This deviceK091026 TDS Abutment for Nobel Biocare ReplacePou YU Biotechnology Co., Ltd. · 2009
- 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
- Descendant · 4 generations on · 22 of its ownK183518 Preat AbutmentsPreat Corporation · 2019 · Recalled
- Descendant · 5 generations on · 8 of its ownK193096 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- 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
- K183518Preat AbutmentsPreat Corporation · 2019 · 4 generations on22descendants
- K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091026 | TDS Abutment for Nobel Biocare Replace | Pou YU Biotechnology Co., Ltd. | 2009 | — |
| +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 | — |
| +4 | K183518 | Preat Abutments | Preat Corporation | 2019 | 3 |
| +5 | K193096 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 8 | 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?
The FDA summary names no predicate by number.
What descends from it? (43)
See all 434 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?
- Of its descendants, K103291 (BioHorizons Implant Systems, Inc., 2011) has gone furthest, with 30 descendants of its own.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
TDS Abutment for Nobel Biocare Replace is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. TDS Abutment for Nobel Biocare Replace is compatible with the following implant systems: Nobel Replace® Select Straight, Nobel Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage, Nobel Replace Straight, Nobel…
Read the full statement (128 words)
TDS Abutment for Nobel Biocare Replace is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
TDS Abutment for Nobel Biocare Replace is compatible with the following implant systems: Nobel Replace® Select Straight, Nobel Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage, Nobel Replace Straight, Nobel Replace Tapered, Nobel Replace Straight Groovy, and Nobel Replace Tapered Groovy for the 3.5 mm (NP), 4.3 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) implants.
Note: Highly angled abutments (i.e. 300) on implants with diameters less than 4 mm are not intended for the posterior region of the mouth due to limited strength of the implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091026 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091026: TDS Abutment for Nobel Biocare Replace.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091026
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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