510(k) · Cleared
ClearedOsseospeed Angled Abutment EV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astra Tech AB · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jan 23, 2013 as substantially equivalent to K111287 (Astra Tech AB, 2011) and 2 other predicates after a 217-day review. Its family tree reaches back 11 generations to 1990. 8 later devices descend from it.
- Decided
- Jan 23, 2013
- Review
- 217 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K894595 (1990). 48 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations between
- 3 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 2 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 1 generation backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- This deviceK121810 Osseospeed Angled Abutment EVAstra Tech AB · 2013
- Descendant · cites it directly · 5 of its ownK160207 ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016
- Descendant · cites it directly · 4 of its ownK163350 Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona · 2017
- Descendant · 2 generations on · 2 of its ownK213449 DS Implants abutments provided with the EV connectionDentsply Sirona · 2021
- Descendant · cites it directly · 1 of its ownK130408 Era Micro 23 Female Abutment, Era Micro 30 Female AbutmentSterngold Dental, LLC · 2013
- Descendant · 3 generations on · 0 of its ownK220841 PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV…Dentsply Sirona · 2022
Show all 11 generations
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 9 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 8 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 7 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 6 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 5 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 4 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 3 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 2 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 1 generation backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- This deviceK121810 Osseospeed Angled Abutment EVAstra Tech AB · 2013
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016 · cites it directly5descendants
- K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona · 2017 · cites it directly4descendants
- K213449DS Implants abutments provided with the EV connectionDentsply Sirona · 2021 · 2 generations on2descendants
- K130408Era Micro 23 Female Abutment, Era Micro 30 Female AbutmentSterngold Dental, LLC · 2013 · cites it directly1descendant
- K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −10 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −9 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −8 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −7 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −6 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −5 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −4 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −3 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −2 | K111287 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −1 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
| 0 (this device) | K121810 | Osseospeed Angled Abutment EV | Astra Tech AB | 2013 | — |
| +1 | K160207 | ATLANTIS ISUS Implant Suprastructures | Dentsply International, Inc. | 2016 | — |
| +1 | K163350 | Multibase Abutments EV and ATLANTIS Suprastructures | Dentsply Sirona | 2017 | — |
| +2 | K213449 | DS Implants abutments provided with the EV connection | Dentsply Sirona | 2021 | — |
| +1 | K130408 | Era Micro 23 Female Abutment, Era Micro 30 Female Abutment | Sterngold Dental, LLC | 2013 | — |
| +3 | K220841 | PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection… | Dentsply Sirona | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K111287 | Astra Tech Implant SystemSummary page 2…ovided in three platform diameters (3.6, 4.2 and 4.8 mm) and two angles (200 and 300). It is intended to fit Astra Tech implants of corresponding diameters cleared under K1 11287 and K120414. All abutments with a 2 0 angle are provided in two gingival heights (1.0 and 2.0 mm) with an indexed or non-indexed… | 2011 |
| * | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantSummary page 2…ment EV is substantially equivalent in indications and design principles to the following legally marketed predicate devices: Astra Tech AB - K111287 Astra Tech, Inc. - K 11213 8 Astra Tech, Inc. - K1 10356 5 10(k) Summary OsseoSpeedTM Angled Abutm… | 2011 |
| * | K110356 | Atlantis Crown Abutment, Atlantis Gemini +(TM) AbutmentSummary page 2…valent in indications and design principles to the following legally marketed predicate devices: Astra Tech AB - K111287 Astra Tech, Inc. - K 11213 8 Astra Tech, Inc. - K1 10356 5 10(k) Summary OsseoSpeedTM Angled Abutment LV The purpose of thi… | 2011 |
What descends from it? (8)
3 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 23 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 5 of the 48 ancestors have a recall of any class.
- Of its descendants, K160207 (Dentsply International, Inc., 2016) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K111287.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
OsseoSpeed Tm Angled Abutment BY is intended to be used in conjunction with Astra Tech Implant System BY in fully edentulous or partially edentulous maxillary and/ar mandibular arches to provide support for bridges or overdentures. The Atlantisgh Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses, in…
Read the full statement (167 words)
OsseoSpeed Tm Angled Abutment BY is intended to be used in conjunction with Astra Tech Implant System BY in fully edentulous or partially edentulous maxillary and/ar mandibular arches to provide support for bridges or overdentures.
The Atlantisgh Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
The Atlantisgh Crown Abutment in Zircania is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in -partially or completely edentulous patients. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant.
Atlantism Abutment and AtlanI~ Crown Abutment are compatible with 05.4 Astra Tech Implant System By.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121810 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121810: Osseospeed Angled Abutment EV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121810
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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