510(k) · Cleared
ClearedCreoDent Solidex Customized 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 Jun 4, 2015 as substantially equivalent to K113738 (Creodent Prosthetics, Ltd., 2013) after a 150-day review. Its family tree reaches back 10 generations to 1990. 6 later devices descend from it.
- Decided
- Jun 4, 2015
- Review
- 150 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K894595 (1990). 77 ancestors in all, the oldest K871863 (1987). 6 later devices descend from it, 5 citing it directly.
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations between
- 3 generations backK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
- 2 generations backK091756 Nobelprocera TI AbutmentNobel Biocare AB · 2009
- 1 generation backK113738 Creodent Solidex Custom AbutmentCreodent Prosthetics, Ltd. · 2013
- This deviceK150012 CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK162734 CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK220390 CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK202909 CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK202095 CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK170100 CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd. · 2017
Show all 10 generations
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 8 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 7 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 6 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 5 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 4 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 3 generations backK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
- 2 generations backK091756 Nobelprocera TI AbutmentNobel Biocare AB · 2009
- 1 generation backK113738 Creodent Solidex Custom AbutmentCreodent Prosthetics, Ltd. · 2013
- This deviceK150012 CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K162734CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd. · 2017 · cites it directly1descendant
- K220390CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd. · 2022 · cites it directly0descendants
- K202909CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd. · 2021 · 2 generations on0descendants
- K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd. · 2020 · cites it directly0descendants
- K170100CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −9 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −8 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −7 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −6 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −5 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −4 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −3 | K062749 | SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP… | Nobel Biocare AB | 2006 | — |
| −2 | K091756 | Nobelprocera TI Abutment | Nobel Biocare AB | 2009 | — |
| −1 | K113738 | Creodent Solidex Custom Abutment | Creodent Prosthetics, Ltd. | 2013 | — |
| 0 (this device) | K150012 | CreoDent Solidex Customized Abutment | Creodent Prosthetics, Ltd. | 2015 | — |
| +1 | K162734 | CreoDent Solidex Customized Abutment | Creodent Prosthetics, Ltd. | 2017 | — |
| +1 | K220390 | CreoDent Solidex Customized Abutment and Screw | Creodent Prosthetics, Ltd. | 2022 | — |
| +2 | K202909 | CreoDent Solidex Customized Abutment | Creodent Prosthetics, Ltd. | 2021 | — |
| +1 | K202095 | CreoDent Solidex Customized Abutment and Screw | Creodent Prosthetics, Ltd. | 2020 | — |
| +1 | K170100 | CreoDent Solidex Customized Abutment and Screw | Creodent Prosthetics, Ltd. | 2017 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K113738 | Creodent Solidex Custom AbutmentSummary page 5…butments are substantially equivalent in intended use, material, design and performance to: • Primary Predicate o Creodent Solidex Customlized Abutments (K113738) • Reference Predicates o Biomet 3i Encode Patient Specific Dental Abutments (K101608) o Straumann Cares… | 2013 |
| † | K101608 | Biomet 3I Patient Specific Dental Abutments-Encode Abutments | 2011 |
| † | K082764 | Straumann WN Cares Titanium Abutment | 2008 |
What descends from it? (6)
5 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 25 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 10 of the 77 ancestors have a recall of any class.
- Of its descendants, K162734 (Creodent Prosthetics, Ltd., 2017) has gone furthest, with 1 descendant 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. 2015, 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 endentulous. 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:
Biomet 3i Osseotite Certain Dental Implants 3.25mm, 4.0mm, 5.0mm, 6.0mm
Straumann Bone Level Implants 3.3mm, 4.1mm, 4.8mm
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150012 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150012: CreoDent Solidex Customized Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150012
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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