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 Apr 11, 2025 as substantially equivalent to K193529 (Dentsply Sirona, 2020) after an 88-day review. Its family tree reaches back 16 generations to 1990. 2 later devices descend from it.
- Decided
- Apr 11, 2025
- Review
- 88 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K894595 (1990). 162 ancestors in all, the oldest K781060 (1978). 2 later devices descend from it, 2 citing it directly.
- Root · 16 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 12 generations between
- 3 generations backK160626 ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona · 2016
- 2 generations backK172225 Atlantis Abutment for MIS ImplantDentsply Sirona · 2017
- 1 generation backK193529 ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona · 2020
- This deviceK250081 Atlantis® Abutments in TitaniumDentsply Sirona · 2025
- Descendant · cites it directly · 0 of its ownK252343 Atlantis® Abutments in TitaniumDentsply Sirona · 2025
- Descendant · cites it directly · 0 of its ownK251205 Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM…Dentsply Sirona · 2025
Show all 16 generations
- Root · 16 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 15 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 14 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 13 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 12 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 11 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 10 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 9 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 8 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 7 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 6 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 5 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
- 4 generations backK130999 Osseospeed Profile EVDentsply Implants Manufacturing GmbH · 2013
- 3 generations backK160626 ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona · 2016
- 2 generations backK172225 Atlantis Abutment for MIS ImplantDentsply Sirona · 2017
- 1 generation backK193529 ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona · 2020
- This deviceK250081 Atlantis® Abutments in TitaniumDentsply Sirona · 2025
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 |
|---|---|---|---|---|---|
| −16 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −15 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −14 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −13 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −12 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −11 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −10 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −9 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −8 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −7 | K111287 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −6 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
| −5 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| −4 | K130999 | Osseospeed Profile EV | Dentsply Implants Manufacturing GmbH | 2013 | — |
| −3 | K160626 | ATLANTIS Abutment for HIOSSEN ET implant | Dentsply Sirona | 2016 | — |
| −2 | K172225 | Atlantis Abutment for MIS Implant | Dentsply Sirona | 2017 | — |
| −1 | K193529 | ATLANTIS Abutment for MIS Conical Connection Implants | Dentsply Sirona | 2020 | — |
| 0 (this device) | K250081 | Atlantis® Abutments in Titanium | Dentsply Sirona | 2025 | — |
| +1 | K252343 | Atlantis® Abutments in Titanium | Dentsply Sirona | 2025 | — |
| +1 | K251205 | Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (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 |
|---|---|---|---|
| * | K193529 | ATLANTIS Abutment for MIS Conical Connection ImplantsSummary page 6…pdate the safety in an MR environment to indicate MR Conditional. This includes a total of 11 implant system compatibilities/clearances. The predicate device, K193529, which is an Atlantis® Abutment specifically compatible with the MIS Conical Connection implant system, represents the most… | 2020 |
| † | K161030 | ATLANTIS Abutment for CONELOG implant | 2016 |
| † | K151039 | ATLANTIS Abutment for NobelActive 3.0 | 2016 |
| † | K081666 | Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0 Implants | 2008 |
| † | K073258 | Atlantis Abutment for Biohorizon Implants, Atlantis Gemini Abutment for Biohorizon… | 2008 |
| † | K070833 | Atlantis Abutment for Astra Implant | 2007 |
| † | K062197 | Atlantis Abutment for 3I Certain Micro Mini; Gemini and Gemini+ Abutment | 2007 |
| † | K062069 | Atlantis Abutment for 3I Micromini Implant | 2007 |
| † | K051652 | Atlantis Abutment, Atlantis Gemini Abutment, Atlantis Gemini+ Abutment | 2005 |
| † | K051011 | Endosseous Dental Implant Abutment | 2005 |
| † | K981858 | Atlantis Abutment and Atlantis Abutment Screw | 1999 |
| † | K221094 | OmniTaper EV Dental Implants, DS Implants abutments with EV connection | 2022 |
| † | K151439 | Atlantis Isus | 2016 |
| † | K151455 | 3Shape Abutment Designer Software | 2016 |
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 35 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 15 of the 162 ancestors have a recall of any class.
- Of its descendants, K252343 (Dentsply Sirona, 2025) has gone furthest, with 0 descendants of its own.
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?
Atlantis Abutment & Atlantis Abutment Milling 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. Atlantis Crown Abutment The…
Read the full statement (517 words)
Atlantis Abutment & Atlantis Abutment Milling
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.
Atlantis Crown Abutment
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.
Atlantis Conus Abutment
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.
Atlantis Healing Abutment
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.
Implant Manufacturer: Dentsply Sirona
Implant System: OsseoSpeed/OsseoSpeed TX
Implant Diameter (in mm): 3.0 (Yellow), 3.5, 4.0 (Aqua), 4.5, 5.0 (Lilac), 4.0 (Blue - Previous)
Abutment Platform Diameter (in mm): 2.330 (Yellow), 2.866 (Aqua), 3.865 (Lilac), 3.368 (Blue - Previous)
Implant Manufacturer: MIS Implant Technologies Inc.
Implant System: V3 (NP, SP), C1 (NP, SP, WP)
Implant Diameter (in mm): V3: 3.30 (NP), 3.90, 4.3, 5.0 (SP); C1: 3.30 (NP), 3.75, 4.2 (SP), 5.0 (WP)
Abutment Platform Diameter (in mm): V3: 2.765 (NP), 3.16 (SP); C1: 2.76 (NP), 3.16 (SP), 4.01 (WP)
Implant Manufacturer: Altatec GmbH
Implant System: Conelog Screw-Line Implant
Implant Diameter (in mm): 3.3, 3.8, 4.3, 5.0
Abutment Platform Diameter (in mm): 2.80 (3.3), 3.00 (3.8, 4.3), 3.80 (5.0)
Implant Manufacturer: Nobel Biocare
Implant System: NobelActive
Implant Diameter (in mm): 3.0
Abutment Platform Diameter (in mm): 2.461
Implant System: Branemark System (NP, RP, WP)
Implant Diameter (in mm): 3.3 (NP), 3.75, 4.0 (RP), 5.0, 5.5 (WP)
Abutment Platform Diameter (in mm): 3.476 (NP), 4.069 (RP), 5.033 (WP)
Implant Manufacturer: BioHorizons
Implant System: Prodigy System Internal/Tapered Internal
Implant Diameter (in mm): 3.5, 4.5, 5.7
Abutment Platform Diameter (in mm): 3.434 (3.5), 4.399 (4.5), 5.644 (5.7)
Implant System: Maestro
Implant Diameter (in mm): 3.5, 4.0, 5.0
Abutment Platform Diameter (in mm): 3.708 (3.5), 4.242 (4.0), 5.258 (5.0)
Implant Manufacturer: Biomet 3i
Implant System: Certain, Certain Prevail, Certain XP
Implant Diameter (in mm): Certain: 3.25, 4, 5, 6; Certain Prevail: 3.4, 4, 5; Certain XP: 5, 6
Abutment Platform Diameter (in mm): 3.404 (3.25, 3.4), 4.012 (4), 4.942 (5), 5.951 (6)
Implant System: Osseotite Tapered and Osseotite Parallel Walled
Implant Diameter (in mm): 3.25, 3.75, 4.0, 5.0, 6.0
Abutment Platform Diameter (in mm): 4.056 (3.25, 3.75, 4.0), 4.978 (5.0), 5.985 (6.0)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250081 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250081: Atlantis® Abutments in Titanium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250081
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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