510(k) · Cleared
ClearedConometric Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Sirona, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jul 10, 2019 as substantially equivalent to K140347 (Dentsply Intl., Inc., 2014) after a 247-day review. Its family tree reaches back 9 generations to 1990.
- Decided
- Jul 10, 2019
- Review
- 247 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K894595 (1990). 23 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK041509 Ankylos Dental Implant SystemFriadent GmbH · 2004
- 2 generations backK083805 Ankylos C/X Dental Implant SystemDentsply Intl., Inc. · 2009
- 1 generation backK140347 Ankylos C/X Implant SystemDentsply Intl., Inc. · 2014
- This deviceK183079 Conometric AbutmentsDentsply Sirona, Inc. · 2019
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 backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 6 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 5 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 4 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 3 generations backK041509 Ankylos Dental Implant SystemFriadent GmbH · 2004
- 2 generations backK083805 Ankylos C/X Dental Implant SystemDentsply Intl., Inc. · 2009
- 1 generation backK140347 Ankylos C/X Implant SystemDentsply Intl., Inc. · 2014
- This deviceK183079 Conometric AbutmentsDentsply Sirona, Inc. · 2019
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 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −6 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −5 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −4 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −3 | K041509 | Ankylos Dental Implant System | Friadent GmbH | 2004 | — |
| −2 | K083805 | Ankylos C/X Dental Implant System | Dentsply Intl., Inc. | 2009 | — |
| −1 | K140347 | Ankylos C/X Implant System | Dentsply Intl., Inc. | 2014 | — |
| 0 (this device) | K183079 | Conometric Abutments | Dentsply Sirona, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 30.7 · 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 |
|---|---|---|---|
| * | K140347 | Ankylos C/X Implant SystemSummary page 4…ous) 3.0 Predicate Device: Predicate Device Name 510(k) Company Name Ankylos® C/X Dental Implant System K140347 Dentsply Sirona (Ankylos® Regular Abutments) Reference Device Name 510(k) C… | 2014 |
| † | K120414 | Osseospeed Plus | 2012 |
| † | K073075 | Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant Systems | 2008 |
| † | K172225 | Atlantis Abutment for MIS Implant | 2017 |
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 29 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 23 ancestors have a recall of any class.
- 1 other device also cites its predicate K140347.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Conometric Abutments are intended to be used in conjunction with the Conometric Final Cap and Ankylos C/X implants, OsseoSpeed EV implants, and Xive S implants to support fixed friction retained single crowns, in mandible or maxilla, in a partially or completely edentulous patient. This system is intended for delayed loading. The Conometric Abutment including the abutment screw and the Conometric Final Cap make up the final abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183079 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183079: Conometric Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183079
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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