510(k) · Cleared
ClearedCreodent Solidex Custom Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Creodent Prosthetics, Ltd. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Sep 17, 2013 as substantially equivalent to K091026 (Pou YU Biotechnology Co., Ltd., 2009) and 2 other predicates after a 637-day review. Its family tree reaches back 9 generations to 1990. 7 later devices descend from it.
- Decided
- Sep 17, 2013
- Review
- 637 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K894595 (1990). 76 ancestors in all, the oldest K871863 (1987). 7 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
- 1 generation backK091756 Nobelprocera TI AbutmentNobel Biocare AB · 2009
- This deviceK113738 Creodent Solidex Custom AbutmentCreodent Prosthetics, Ltd. · 2013
- Descendant · cites it directly · 6 of its ownK150012 CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd. · 2015
- Descendant · 2 generations on · 1 of its ownK162734 CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK220390 CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK202909 CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK202095 CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd. · 2020
Show all 9 generations
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 7 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 6 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 5 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 4 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
- 1 generation backK091756 Nobelprocera TI AbutmentNobel Biocare AB · 2009
- This deviceK113738 Creodent Solidex Custom AbutmentCreodent Prosthetics, Ltd. · 2013
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K150012CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd. · 2015 · cites it directly6descendants
- K162734CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd. · 2017 · 2 generations on1descendant
- K220390CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd. · 2022 · 2 generations on0descendants
- K202909CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd. · 2021 · 3 generations on0descendants
- K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −8 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −7 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −6 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −5 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −4 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −3 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −2 | K062749 | SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP… | Nobel Biocare AB | 2006 | — |
| −1 | K091756 | Nobelprocera TI Abutment | Nobel Biocare AB | 2009 | — |
| 0 (this device) | K113738 | Creodent Solidex Custom Abutment | Creodent Prosthetics, Ltd. | 2013 | — |
| +1 | K150012 | CreoDent Solidex Customized Abutment | Creodent Prosthetics, Ltd. | 2015 | — |
| +2 | K162734 | CreoDent Solidex Customized Abutment | Creodent Prosthetics, Ltd. | 2017 | — |
| +2 | K220390 | CreoDent Solidex Customized Abutment and Screw | Creodent Prosthetics, Ltd. | 2022 | — |
| +3 | K202909 | CreoDent Solidex Customized Abutment | Creodent Prosthetics, Ltd. | 2021 | — |
| +2 | K202095 | CreoDent Solidex Customized Abutment and Screw | Creodent Prosthetics, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 10 | 0 |
| 1994 | 9 | 0 |
| 1995 | 7 | 0 |
| 1996 | 9 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K091026 | TDS Abutment for Nobel Biocare ReplaceSummary page 2…d Abutments are substantially equivalent in intended use, material, design and performance to: * Nobel TIDS Abutment for Nobel Biocare Replace and Abutment Screw 510K#091026 * Nobel Procera Ti Abutment and Abutment Screw 510K#091 756 " Zimmer Patient-Specific Abutment, Internal Hex Titanium and A… | 2009 |
| * | K091756 | Nobelprocera TI AbutmentSummary page 4…K#113738 - Abutment and Abutment Screw 51OK9091756 MRaterial -Abutment: CP Ti Gr4 unalloyed -Abutment: Comparable Titanium… | 2009 |
| * | K071439 | Zimmer Patient-Specific Abutment, Internal Hex, TitaniumSummary page 2…crew 510K#091026 * Nobel Procera Ti Abutment and Abutment Screw 510K#091 756 " Zimmer Patient-Specific Abutment, Internal Hex Titanium and Abutment Screw 510K#071439 Conclusion: The Creodent Solidex® Customized Abutments are substantially equivalent to the identified predicate products noted in… | 2007 |
| † | K023113 | Replace Tiunite Endosseous Implant | 2002 |
| † | K071370 | Nobelactive Internal Connection Implant | 2007 |
| † | K013227 | Screw Vent Implant; Tapered Screw Vent Implant | 2001 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150012 | CreoDent Solidex Customized Abutment | 2015 | 6 |
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 23 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 10 of the 76 ancestors have a recall of any class.
- Of its descendants, K150012 (Creodent Prosthetics, Ltd., 2015) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K091026.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant. The CreoDent Solidex® Customized Abutment is compatible with the following…
Read the full statement (105 words)
The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.
The CreoDent Solidex® Customized Abutment is compatible with the following:
* Nobel Replace TiUnite Endosseous 3.5mm, 4.3mm, and 5.0mm diameter Implants
* Nobel Active Internal Connection 3.5mm and 4.3mm diameter Implants
* Zimmer Screw-Vent 3.7mm, 4.7mm; Zimmer Tapered Screw-Vent 3.7mm, 4.7mm and 6.0mm diameter Implants
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113738 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113738: Creodent Solidex Custom Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113738
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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