510(k) · Cleared
ClearedTDS Abutment for Friadent Xive
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 Mar 31, 2011 as substantially equivalent to K032302 (Friadent GmbH, 2003) and 2 other predicates after a 136-day review. Its family tree reaches back 11 generations to 1996. 3 later devices descend from it.
- Decided
- Mar 31, 2011
- Review
- 136 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K960026 (1996). 125 ancestors in all, the oldest K830955 (1983). 3 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 7 generations between
- 3 generations backK050506 Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc. · 2005
- 2 generations backK051614 Primaconnex Internal Connection Implant System, Primaconnex Internal…Lifecore Biomedical, Inc. · 2005 · Recalled
- 1 generation backK072241 Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc. · 2007
- This deviceK103339 TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK150296 Biodenta Customized Abutment-HybridBiodenta Swiss AG · 2015
- Descendant · cites it directly · 0 of its ownK131468 Denracle Dental AbutmentGreen Dentech Co, Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK121117 NDX AbutmentsNational Dentex Corp · 2012
Show all 11 generations
- Root · 11 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 10 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 9 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 8 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 7 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 5 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 4 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 3 generations backK050506 Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc. · 2005
- 2 generations backK051614 Primaconnex Internal Connection Implant System, Primaconnex Internal…Lifecore Biomedical, Inc. · 2005 · Recalled
- 1 generation backK072241 Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc. · 2007
- This deviceK103339 TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd. · 2011
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −10 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −9 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −8 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −7 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −5 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −4 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −3 | K050506 | Primasolo One-Piece Implants & Healing Caps | Lifecore Biomedical, Inc. | 2005 | — |
| −2 | K051614 | Primaconnex Internal Connection Implant System, Primaconnex Internal… | Lifecore Biomedical, Inc. | 2005 | 5 |
| −1 | K072241 | Primaconnex Cad/Cam Abutment System | Lifecore Biomedical, Inc. | 2007 | — |
| 0 (this device) | K103339 | TDS Abutment for Friadent Xive | Pou YU Biotechnology Co., Ltd. | 2011 | — |
| +1 | K150296 | Biodenta Customized Abutment-Hybrid | Biodenta Swiss AG | 2015 | — |
| +1 | K131468 | Denracle Dental Abutment | Green Dentech Co, Ltd. | 2014 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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? (3)
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 |
|---|---|---|---|
| * | K032302 | Xive TG AbutmentsSummary page 1…Panel: Dental Products Panel Reviewing Branch: Dental Devices Branch LEGALLY MARKETED DEVICES FRIADENT GmbH. - Xive TG Abutments -K032302 Lifecore Biomedical Inc. - PrimaConnex® CAD/CAM Abutment System- K072241 Atlantis Components, Inc. - Atlantis TmAbutment in Zirco… | 2003 |
| * | K072241 | Primaconnex Cad/Cam Abutment SystemSummary page 1…Dental Devices Branch LEGALLY MARKETED DEVICES FRIADENT GmbH. - Xive TG Abutments -K032302 Lifecore Biomedical Inc. - PrimaConnex® CAD/CAM Abutment System- K072241 Atlantis Components, Inc. - Atlantis TmAbutment in Zirconia for 3i Certain Interface- K063734. DEVICE DESCRIPTION TDS Abutmen… | 2007 |
| * | K063734 | Atlantis Abutment in Zirconia for 3I Certain InterfaceSummary page 1…s -K032302 Lifecore Biomedical Inc. - PrimaConnex® CAD/CAM Abutment System- K072241 Atlantis Components, Inc. - Atlantis TmAbutment in Zirconia for 3i Certain Interface- K063734. DEVICE DESCRIPTION TDS Abutment for Friadent Xive are titanium and ceramic-titanium abutments designed to be used in conjunc… | 2007 |
What descends from it? (3)
3 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 15 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- 12 of the 125 ancestors have a recall of any class.
- Of its descendants, K150296 (Biodenta Swiss AG, 2015) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K032302.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Friadent Xive 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. This device is compatible with the following implant systems which have an internal hex with flat-to-flat dimensions of 1.78mm or greater: Firadent: FRIALIT Implant, XiVA Implant; 3i: Internal Connect Type; Astra: Osseoispeed Implant, Osseospeed TX Implant…
Read the full statement (108 words)
TDS Abutment for Friadent Xive 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.
This device is compatible with the following implant systems which have an internal hex with flat-to-flat dimensions of 1.78mm or greater: Firadent: FRIALIT Implant, XiVA Implant; 3i: Internal Connect Type; Astra: Osseoispeed Implant, Osseospeed TX Implant; BioHorizons: Internal Implant System, Tapered Internal Implant System, Single-Stage Implant System, Laser-lok®& 3.0 implant system; Lifecore:,Lifecore RENOVATM Internal Hex Implant System; Zimimer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System; Osstem: GS System; Nobel Biocare: Active Implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103339 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103339: TDS Abutment for Friadent Xive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103339
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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