510(k) · Cleared
ClearedAtlantis® Abutments in Titanium
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 Dec 9, 2025 as substantially equivalent to K250081 (Dentsply Sirona, 2025) after a 134-day review. Its family tree reaches back 17 generations to 1990.
- Decided
- Dec 9, 2025
- Review
- 134 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K894595 (1990). 163 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 17 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 13 generations between
- 3 generations backK172225 Atlantis Abutment for MIS ImplantDentsply Sirona · 2017
- 2 generations backK193529 ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona · 2020
- 1 generation backK250081 Atlantis® Abutments in TitaniumDentsply Sirona · 2025
- This deviceK252343 Atlantis® Abutments in TitaniumDentsply Sirona · 2025
Show all 17 generations
- Root · 17 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 16 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 15 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 14 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 13 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 12 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 11 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 10 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 9 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 8 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 7 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 6 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
- 5 generations backK130999 Osseospeed Profile EVDentsply Implants Manufacturing GmbH · 2013
- 4 generations backK160626 ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona · 2016
- 3 generations backK172225 Atlantis Abutment for MIS ImplantDentsply Sirona · 2017
- 2 generations backK193529 ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona · 2020
- 1 generation backK250081 Atlantis® Abutments in TitaniumDentsply Sirona · 2025
- This deviceK252343 Atlantis® Abutments in TitaniumDentsply Sirona · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −16 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −15 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −14 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −13 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −12 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −11 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −10 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −9 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −8 | K111287 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −7 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
| −6 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| −5 | K130999 | Osseospeed Profile EV | Dentsply Implants Manufacturing GmbH | 2013 | — |
| −4 | K160626 | ATLANTIS Abutment for HIOSSEN ET implant | Dentsply Sirona | 2016 | — |
| −3 | K172225 | Atlantis Abutment for MIS Implant | Dentsply Sirona | 2017 | — |
| −2 | K193529 | ATLANTIS Abutment for MIS Conical Connection Implants | Dentsply Sirona | 2020 | — |
| −1 | K250081 | Atlantis® Abutments in Titanium | Dentsply Sirona | 2025 | — |
| 0 (this device) | K252343 | Atlantis® Abutments in Titanium | Dentsply Sirona | 2025 | — |
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 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 11 | 0 |
| 1994 | 10 | 0 |
| 1995 | 10 | 0 |
| 1996 | 11 | 0 |
| 1997 | 6 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 11 | 0 |
| 2003 | 8 | 0 |
| 2004 | 6 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 6 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 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? (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 |
|---|---|---|---|
| * | K250081 | Atlantis® Abutments in TitaniumSummary page 7…f the Atlantis® Abutments in Titanium to indicate MR Conditional. This includes a total of 10 implant system compatibilities/clearances. The predicate device, K250081, Atlantis® Abutments in Titanium, represents the latest version of the Atlantis® Abutments in Titanium and shares the same i… | 2025 |
| † | K172225 | Atlantis Abutment for MIS Implant | 2017 |
| † | K160626 | ATLANTIS Abutment for HIOSSEN ET implant | 2016 |
| † | K130999 | Osseospeed Profile EV | 2013 |
| † | K111287 | Astra Tech Implant System | 2011 |
| † | K101004 | Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis… | 2010 |
| † | K093483 | Atlantis Abutment for Nobel Biocare Active Implant, Atlantis Gemini Abutment, Gemini +… | 2009 |
| † | K083871 | Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment… | 2009 |
| † | K053654 | Atlantis Abutment for Nobel Replace Interface | 2006 |
| † | K053373 | Atlantis Abutment for Zimmer Interface | 2006 |
| † | K050052 | Atlantis Abutment for Straumann Interface | 2005 |
| † | K151455 | 3Shape Abutment Designer Software | 2016 |
| † | K210610 | PrimeTaper EV Dental Implant | 2021 |
| † | K221094 | OmniTaper EV Dental Implants, DS Implants abutments with EV connection | 2022 |
| † | K220841 | PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS) | 2022 |
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 35 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 15 of the 163 ancestors have a recall of any class.
- 1 other device also cites its predicate K250081.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Atlantis Abutment and Atlantis Abutment Milling are 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 prosthesis, in the mandible or maxilla. The Atlantis Abutment screw is intended to secure the Atlantis Abutment to the endosseous implant. The Atlantis Crown Abutment is intended for use with an endosseous implant to…
Read the full statement (214 words)
The Atlantis Abutment and Atlantis Abutment Milling are 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 prosthesis, in the mandible or maxilla. The Atlantis Abutment screw is intended to secure the Atlantis Abutment to the endosseous implant.
The Atlantis Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The Atlantis Abutment screw is intended to secure the Atlantis Crown Abutment to the endosseous implant.
The Atlantis Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is an attachment- retained by friction fit to the abutment. The Atlantis Abutment screw is intended to secure the Atlantis Conus Abutment to the endosseous implant.
The Atlantis Healing Abutment is intended for use with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The Atlantis Abutment screw is intended to secure the Atlantis Healing Abutment to the endosseous implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252343 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252343: Atlantis® Abutments in Titanium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252343
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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