510(k) · Cleared
ClearedCreoDent Solidex Customized Abutment and Screw
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 Dec 16, 2020 as substantially equivalent to K150012 (Creodent Prosthetics, Ltd., 2015) and 1 other predicate after a 140-day review. Its family tree reaches back 13 generations to 1990.
- Decided
- Dec 16, 2020
- Review
- 140 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K894595 (1990). 130 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations between
- 3 generations backK123784 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- 2 generations backK130222 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- 1 generation backK171784 Straumann Dental Implant SystemStraumann USA, LLC · 2018
- This deviceK202095 CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd. · 2020
Show all 13 generations
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 12 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 11 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 10 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 9 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 8 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 7 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 6 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 5 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 4 generations backK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- 3 generations backK123784 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- 2 generations backK130222 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- 1 generation backK171784 Straumann Dental Implant SystemStraumann USA, LLC · 2018
- This deviceK202095 CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −12 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −11 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −10 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −9 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −8 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −7 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −6 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| −5 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
| −4 | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
| −3 | K123784 | Straumann Dental Implant System | Straumann USA, LLC | 2013 | — |
| −2 | K130222 | Straumann Dental Implant System | Straumann USA, LLC | 2013 | — |
| −1 | K171784 | Straumann Dental Implant System | Straumann USA, LLC | 2018 | — |
| 0 (this device) | 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 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 12 | 0 |
| 1994 | 10 | 0 |
| 1995 | 7 | 0 |
| 1996 | 13 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 6 | 0 |
| 2000 | 2 | 0 |
| 2001 | 8 | 0 |
| 2002 | 7 | 0 |
| 2003 | 7 | 0 |
| 2004 | 7 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 6 | 0 |
| 2009 | 6 | 0 |
| 2012 | 2 | 0 |
| 2013 | 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? (2)
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 |
|---|---|---|---|
| * | K150012 | CreoDent Solidex Customized AbutmentSummary page 6…CreoDent Solidex® Customized Abutments are substantially equivalent in intended use, material, design and performance to: • CreoDent Solidex Customized Abutments (K150012) Primary Predicate • Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5 (K171784) Conclusion: The CreoDent Solidex®… | 2015 |
| * | K171784 | Straumann Dental Implant SystemSummary page 6…rial, design and performance to: • CreoDent Solidex Customized Abutments (K150012) Primary Predicate • Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5 (K171784) Conclusion: The CreoDent Solidex® Customized Abutment and Screw are substantially equivalent to the identified predicate pro… | 2018 |
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 30 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 15 of the 130 ancestors have a recall of any class.
- 4 other devices also cite its predicate K150012.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 and Screw 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 and Screw are compatible with the following:
Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202095 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202095: CreoDent Solidex Customized Abutment and Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202095
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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