510(k) · Cleared
ClearedDS Implants abutments provided with the EV connection
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Sirona · NHA Abutment, Implant, Dental, Endosseous
Cleared on Nov 15, 2021 as substantially equivalent to K120414 (Astra Tech AB, 2012) and 1 other predicate after a 20-day review. Its family tree reaches back 15 generations to 1990. 2 later devices descend from it.
- Decided
- Nov 15, 2021
- Review
- 20 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K894595 (1990). 237 ancestors in all, the oldest K781060 (1978). 2 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations between
- 3 generations backK130999 Osseospeed Profile EVDentsply Implants Manufacturing GmbH · 2013
- 2 generations backK160207 ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016
- 1 generation backK163350 Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona · 2017
- This deviceK213449 DS Implants abutments provided with the EV connectionDentsply Sirona · 2021
- Descendant · cites it directly · 0 of its ownK220841 PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV…Dentsply Sirona · 2022
- Descendant · cites it directly · 0 of its ownK221094 OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona · 2022
Show all 15 generations
- Root · 15 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 14 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 13 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 12 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 11 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 10 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 9 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 8 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 7 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 6 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 5 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 4 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
- 3 generations backK130999 Osseospeed Profile EVDentsply Implants Manufacturing GmbH · 2013
- 2 generations backK160207 ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016
- 1 generation backK163350 Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona · 2017
- This deviceK213449 DS Implants abutments provided with the EV connectionDentsply Sirona · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −14 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −13 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −12 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −11 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −10 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −9 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −8 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −7 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −6 | K111287 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −5 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
| −4 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| −3 | K130999 | Osseospeed Profile EV | Dentsply Implants Manufacturing GmbH | 2013 | — |
| −2 | K160207 | ATLANTIS ISUS Implant Suprastructures | Dentsply International, Inc. | 2016 | — |
| −1 | K163350 | Multibase Abutments EV and ATLANTIS Suprastructures | Dentsply Sirona | 2017 | — |
| 0 (this device) | K213449 | DS Implants abutments provided with the EV connection | Dentsply Sirona | 2021 | — |
| +1 | K220841 | PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection… | Dentsply Sirona | 2022 | — |
| +1 | K221094 | OmniTaper EV Dental Implants, DS Implants abutments with EV connection | Dentsply Sirona | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 6 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 12 | 0 |
| 1994 | 11 | 0 |
| 1995 | 14 | 0 |
| 1996 | 16 | 0 |
| 1997 | 8 | 0 |
| 1998 | 8 | 0 |
| 1999 | 10 | 0 |
| 2000 | 7 | 0 |
| 2001 | 15 | 0 |
| 2002 | 17 | 0 |
| 2003 | 18 | 0 |
| 2004 | 11 | 0 |
| 2005 | 9 | 0 |
| 2006 | 5 | 0 |
| 2007 | 10 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 8 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 30.6 · 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 |
|---|---|---|---|
| * | K120414 | Osseospeed PlusSummary page 6…Code Dentsply Sirona OsseoSpeed Plus NHA K120414 (formerly: Astra Tech AB) Pr… | 2012 |
| * | K163350 | Multibase Abutments EV and ATLANTIS SuprastructuresSummary page 6…510(k) Company Name Device Name Code Multibase Abutments EV and ATLANTIS NHA K163350 Dentsply Sirona Suprastructures NOTE: The OsseoSpeed Plus K120414 clearance included the Astra Tech Implan… | 2017 |
| † | K030639 | Xive 3.0 Dental Implant System | 2003 |
| † | K945847 | Frialit (R)-2 Stepped Screw with Deep Profile Surface | 1996 |
What descends from it? (2)
2 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 31 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 23 of the 237 ancestors have a recall of any class.
- Of its descendants, K220841 (Dentsply Sirona, 2022) has gone furthest, with 0 descendants of its own.
- 26 other devices also cite its predicate K120414.
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?
DS Implants abutments provided with the EV connection are intended to be used in conjunction with implants with the EV connection in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.
DS Implants abutments provided with the EV connection are intended to be used in conjunction with implants with the EV connection in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213449: DS Implants abutments provided with the EV connection.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213449
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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