510(k) · Cleared
ClearedNDX Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
National Dentex Corp · NHA Abutment, Implant, Dental, Endosseous
Cleared on Dec 14, 2012 as substantially equivalent to K103339 (Pou YU Biotechnology Co., Ltd., 2011) and 3 other predicates after a 246-day review. Its family tree reaches back 12 generations to 1996.
- Decided
- Dec 14, 2012
- Review
- 246 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K960026 (1996). 129 ancestors in all, the oldest K830955 (1983). No later device cites it as a predicate yet.
- Root · 12 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 8 generations between
- 3 generations backK051614 Primaconnex Internal Connection Implant System, Primaconnex Internal…Lifecore Biomedical, Inc. · 2005 · Recalled
- 2 generations backK072241 Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc. · 2007
- 1 generation backK103339 TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd. · 2011
- This deviceK121117 NDX AbutmentsNational Dentex Corp · 2012
Show all 12 generations
- Root · 12 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 11 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 10 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 9 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 8 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 7 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 5 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 4 generations backK050506 Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc. · 2005
- 3 generations backK051614 Primaconnex Internal Connection Implant System, Primaconnex Internal…Lifecore Biomedical, Inc. · 2005 · Recalled
- 2 generations backK072241 Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc. · 2007
- 1 generation backK103339 TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd. · 2011
- This deviceK121117 NDX AbutmentsNational Dentex Corp · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −11 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −10 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −9 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −8 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −7 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −5 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −4 | K050506 | Primasolo One-Piece Implants & Healing Caps | Lifecore Biomedical, Inc. | 2005 | — |
| −3 | K051614 | Primaconnex Internal Connection Implant System, Primaconnex Internal… | Lifecore Biomedical, Inc. | 2005 | 5 |
| −2 | K072241 | Primaconnex Cad/Cam Abutment System | Lifecore Biomedical, Inc. | 2007 | — |
| −1 | K103339 | TDS Abutment for Friadent Xive | Pou YU Biotechnology Co., Ltd. | 2011 | — |
| 0 (this device) | K121117 | NDX Abutments | National Dentex Corp | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 10 | 0 |
| 1994 | 13 | 0 |
| 1995 | 9 | 0 |
| 1996 | 8 | 0 |
| 1997 | 6 | 0 |
| 1998 | 7 | 0 |
| 1999 | 11 | 0 |
| 2000 | 6 | 0 |
| 2001 | 8 | 0 |
| 2002 | 7 | 0 |
| 2003 | 8 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 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 |
|---|---|---|---|
| * | K103339 | TDS Abutment for Friadent XiveSummary page 3…equivalent in indications and design principles to the following predicate devices, all manufactured by Pou Yu Biotechnology Co., Ltd.: TDS Abutment for Friadent Xive - K103339, TDS Titanium Abutment for Nobel Biocare Brdnemark - K091392, TDS Abutment for Nobel Biocare Replace - K091 026, and TDS Abutment… | 2011 |
| * | K091392 | TDS Titanium Abutment for Nobel Biocare BranemarkSummary page 3…ing predicate devices, all manufactured by Pou Yu Biotechnology Co., Ltd.: TDS Abutment for Friadent Xive - K103339, TDS Titanium Abutment for Nobel Biocare Brdnemark - K091392, TDS Abutment for Nobel Biocare Replace - K091 026, and TDS Abutment - K08 1460 The purpose of this submission is to give Nation… | 2009 |
| * | K091026 | TDS Abutment for Nobel Biocare ReplaceSummary page 3…Biotechnology Co., Ltd.: TDS Abutment for Friadent Xive - K103339, TDS Titanium Abutment for Nobel Biocare Brdnemark - K091392, TDS Abutment for Nobel Biocare Replace - K091 026, and TDS Abutment - K08 1460 The purpose of this submission is to give National Dentex Corporation the ability to utilize the cu… | 2009 |
| * | K081460 | TDS AbutmentSummary page 3…Abutment for Friadent Xive - K103339, TDS Titanium Abutment for Nobel Biocare Brdnemark - K091392, TDS Abutment for Nobel Biocare Replace - K091 026, and TDS Abutment - K08 1460 The purpose of this submission is to give National Dentex Corporation the ability to utilize the currently cleared TDS CAD/CAM A… | 2008 |
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 16 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 12 of the 129 ancestors have a recall of any class.
- 2 other devices also cite its predicate K103339.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
NDX Custom Abutments are 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. NDX Abutment for Nobel Biocare Brilnemark is compatible with the following implant systems: Nobel Biocare: Brilnemark System® Mk III Groovy Brinemark System®@ Mk Ill Shorty Brilnemark System®g Zygoma NobelSpeedy Groovy NobelSpeedy Shorty NDX Abutment for Nobel Biocare…
Read the full statement (188 words)
NDX Custom Abutments are 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.
NDX Abutment for Nobel Biocare Brilnemark is compatible with the following implant systems:
Nobel Biocare: Brilnemark System® Mk III Groovy
Brinemark System®@ Mk Ill Shorty
Brilnemark System®g Zygoma
NobelSpeedy Groovy
NobelSpeedy Shorty
NDX Abutment for Nobel Biocare Replace is compatible with the following implant systems:
Nobel Biocare: Nobel Replace® Select Straight
Nobel Replace Select Straight One Stage
Replace Select Tapered
Replace Select Tapered One Stage
Nobel Replace Straight
Nobel Replace Tapered
Nobel Replace Straight Groovy
Nobel Replace Tapered Groovy for the 3.5 mm (NP)
4.3 mm (RP), 5.0 mm (WP) and 6.0 mm implants
NDX Abutment for Nobel Active is compatible with the following implant system:
Nobel Biocare: NobelActive Implant
NDX Abutment for 3i External Hex is compatible with the following implant systems:
3i: NanoTite External Hex Connection Implants
Full OSSEOTITE External Hex Connection Implants
OSSEOTITE External Hex Connection Implant
NDX Abutment for 3i Certain Internal is compatible with the following implant system:
3i: Certain Internal Connection
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121117: NDX Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121117
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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