510(k) · Cleared
ClearedDenracle Dental Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Green Dentech Co, Ltd. · NHA Abutment, Implant, Dental, Endosseous
Cleared on May 6, 2014 as substantially equivalent to K103339 (Pou YU Biotechnology Co., Ltd., 2011) after a 350-day review. Its family tree reaches back 12 generations to 1996.
- Decided
- May 6, 2014
- Review
- 350 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K960026 (1996). 126 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 deviceK131468 Denracle Dental AbutmentGreen Dentech Co, Ltd. · 2014
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 deviceK131468 Denracle Dental AbutmentGreen Dentech Co, Ltd. · 2014
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) | K131468 | Denracle Dental Abutment | Green Dentech Co, Ltd. | 2014 | — |
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 |
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 |
|---|---|---|---|
| * | K103339 | TDS Abutment for Friadent XiveSummary page 1…sification Panel: Dental Products Panel Reviewing Branch: Dental Devices 3. LEGALLY MARKETED DEVICES TDS Abutment for Friadent Xive - K1 03339. 4. DEVICE DESCRIPTION Denracle Dental Abutment for Osstem GS Implant are titanium abutments designed to be used in conju… | 2011 |
| † | K072896 | GS Fixture System | 2007 |
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 18 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 12 of the 126 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. 2014, 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?
Denracle Dental Abutment for OSSTEM GS Implant is intended for use with dental implant as a support for single or multiple tooth prostheses in maxilla or mandible of a partially or fully edentulous patient.
This device is compatible with the following implant system: OSSTEM GS Fixture System ø4.0mm ø4.5mm ø5.0mm
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131468 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131468: Denracle Dental Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131468
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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