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 Apr 2, 2021 as substantially equivalent to K162734 (Creodent Prosthetics, Ltd., 2017) after a 185-day review. Its family tree reaches back 12 generations to 1990.
- Decided
- Apr 2, 2021
- Review
- 185 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K894595 (1990). 79 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations between
- 3 generations backK113738 Creodent Solidex Custom AbutmentCreodent Prosthetics, Ltd. · 2013
- 2 generations backK150012 CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd. · 2015
- 1 generation backK162734 CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd. · 2017
- This deviceK202909 CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd. · 2021
Show all 12 generations
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 10 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 9 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 8 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 7 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 6 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 5 generations backK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
- 4 generations backK091756 Nobelprocera TI AbutmentNobel Biocare AB · 2009
- 3 generations backK113738 Creodent Solidex Custom AbutmentCreodent Prosthetics, Ltd. · 2013
- 2 generations backK150012 CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd. · 2015
- 1 generation backK162734 CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd. · 2017
- This deviceK202909 CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −11 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −10 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −9 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −8 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −7 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −6 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −5 | K062749 | SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP… | Nobel Biocare AB | 2006 | — |
| −4 | K091756 | Nobelprocera TI Abutment | Nobel Biocare AB | 2009 | — |
| −3 | K113738 | Creodent Solidex Custom Abutment | Creodent Prosthetics, Ltd. | 2013 | — |
| −2 | K150012 | CreoDent Solidex Customized Abutment | Creodent Prosthetics, Ltd. | 2015 | — |
| −1 | K162734 | CreoDent Solidex Customized Abutment | Creodent Prosthetics, Ltd. | 2017 | — |
| 0 (this device) | K202909 | CreoDent Solidex Customized Abutment | Creodent Prosthetics, Ltd. | 2021 | — |
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 |
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 30.7 · 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 |
|---|---|---|---|
| * | K162734 | CreoDent Solidex Customized AbutmentSummary page 5…and design principles to the following Predicate device. 510(k) Predicate Device Name Company Name K162734 CreoDent Solidex® Customized Abutment CreoDent Prosthetics, Ltd. The primary intent of this submission is t… | 2017 |
| † | K113738 | Creodent Solidex Custom Abutment | 2013 |
| † | K150012 | CreoDent Solidex Customized Abutment | 2015 |
| † | K160436 | CreoDent Solidex Custom Abutment | 2016 |
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 31 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 10 of the 79 ancestors have a recall of any class.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 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…
Read the full statement (383 words)
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 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 dental implants:
Manufacturer Implant Line Platform Implant Body
Diameter (mm) Diameter (mm)
Altatec Biotechnolgies N.A. Incorporated Camlog Screwline Implant Promote 3.3 3.3
Altatec Biotechnolgies N.A. Incorporated Camlog Screwline Implant Promote 3.8 3.8
Altatec Biotechnolgies N.A. Incorporated Camlog Screwline Implant Promote 4.3 4.3
Altatec Biotechnolgies N.A. Incorporated Camlog Screwline Implant Promote 5.0 5.0
Astra Tech, Inc Osseospeed TX Implants 3.5 3.5
Astra Tech, Inc Osseospeed TX Implants 4.5 4.5
Biomet 3i Osseotite Certain Dental Implants 3.4 3.25
Biomet 3i Osseotite Certain Dental Implants 4.1 4.0
Biomet 3i Osseotite Certain Dental Implants 5.0 5.0
Biomet 3i Osseotite Certain Dental Implants 6.0 6.0
Dentium CO., Ltd Dentium 3.6mm Implantium 3.6 3.4
Hiossen Hiossen TS Implants 3.5 (Mini) 3.5
Hiossen Hiossen TS Implants 4.0 (Regular) 4.0
Lifecore Biomedical, Inc PrimaConnex Implants Internal (KeyStone) 3.5 2.4
Lifecore Biomedical, Inc PrimaConnex Implants Internal (KeyStone) 4.1 2.7
Lifecore Biomedical, Inc PrimaConnex Implants Internal (KeyStone) 5.0 3.3
Nobel Biocare NobelActiveTM Internal Connection Implant 3.5 (NP) 3.5
Nobel Biocare NobelActiveTM Internal Connection Implant 3.9 (RP) 4.3
Nobel Biocare NobelReplaceTM TiUnite Endosseous Implant 3.5 (NP) 3.5
Nobel Biocare NobelReplaceTM TiUnite Endosseous Implant 4.3, 5.0 (RP) 4.3, 5.0
Thommen Medical AG SPI Element Dental Implants RC INCELL PF 3.5 3.5
Thommen Medical AG SPI Element Dental Implants RC INCELL PF 4.0 4.0
Thommen Medical AG SPI Element Dental Implants RC INCELL PF 4.5 4.2
Thommen Medical AG SPI Element Dental Implants RC INCELL PF 5.0 5.0
Thommen Medical AG SPI Element Dental Implants RC INCELL PF 6.0 6.0
Straumann Straumann Bone Level (BL) Implants 3.3 (NC) 3.3
Straumann Straumann Bone Level (BL) Implants 4.1, 4.8 (RC) 4.1, 4.8
Zimmer Zimmer Screw-Vent, Tapered Screw-Vent Implant 3.5 3.7
Zimmer Zimmer Screw-Vent, Tapered Screw-Vent Implant 4.5 4.7
Zimmer Zimmer Tapered Screw-Vent Implant 5.7 6.0
All digitally designed files for CreoDent Solidex@ Customized Abutment are to be sent back to a CreoDent-validated manufacturing facility for manufacture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202909 · printed Nov 4, 2026
Cite this page
510(k) Report. “K202909: CreoDent Solidex Customized Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K202909
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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