510(k) · Cleared
ClearedAtlantis Abutment in Zirconia for Osseospeed TX Profile Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astra Tech, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Apr 8, 2011 as substantially equivalent to K080156 (Astra Tech AB, 2008) and 1 other predicate after a 106-day review. Its family tree reaches back 6 generations to 1993. 19 later devices descend from it.
- Decided
- Apr 8, 2011
- Review
- 106 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K925765 (1993). 22 ancestors in all. 19 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 5 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 4 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 3 generations backK062069 Atlantis Abutment for 3I Micromini ImplantAtlantis Components, Inc. · 2007
- 2 generations backK070833 Atlantis Abutment for Astra ImplantAtlantis Components, Inc. · 2007
- 1 generation backK071946 Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra ImplantsAtlantis Components, Inc. · 2007
- This deviceK103759 Atlantis Abutment in Zirconia for Osseospeed TX Profile ImplantAstra Tech, Inc. · 2011
- Descendant · cites it directly · 18 of its ownK130999 Osseospeed Profile EVDentsply Implants Manufacturing GmbH · 2013
- Descendant · 2 generations on · 9 of its ownK160626 ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona · 2016
- Descendant · 3 generations on · 8 of its ownK172225 Atlantis Abutment for MIS ImplantDentsply Sirona · 2017
- Descendant · 2 generations on · 5 of its ownK160207 ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016
- Descendant · 2 generations on · 4 of its ownK163350 Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona · 2017
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH · 2013 · cites it directly18descendants
- K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona · 2016 · 2 generations on9descendants
- K172225Atlantis Abutment for MIS ImplantDentsply Sirona · 2017 · 3 generations on8descendants
- K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016 · 2 generations on5descendants
- K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona · 2017 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −5 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −4 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −3 | K062069 | Atlantis Abutment for 3I Micromini Implant | Atlantis Components, Inc. | 2007 | — |
| −2 | K070833 | Atlantis Abutment for Astra Implant | Atlantis Components, Inc. | 2007 | — |
| −1 | K071946 | Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra Implants | Atlantis Components, Inc. | 2007 | — |
| 0 (this device) | K103759 | Atlantis Abutment in Zirconia for Osseospeed TX Profile Implant | Astra Tech, Inc. | 2011 | — |
| +1 | K130999 | Osseospeed Profile EV | Dentsply Implants Manufacturing GmbH | 2013 | — |
| +2 | K160626 | ATLANTIS Abutment for HIOSSEN ET implant | Dentsply Sirona | 2016 | — |
| +3 | K172225 | Atlantis Abutment for MIS Implant | Dentsply Sirona | 2017 | — |
| +2 | K160207 | ATLANTIS ISUS Implant Suprastructures | Dentsply International, Inc. | 2016 | — |
| +2 | K163350 | Multibase Abutments EV and ATLANTIS Suprastructures | Dentsply Sirona | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 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 |
|---|---|---|---|
| * | K080156 | Osseospeed TM Profile SystemSummary page 3…Zirconia for Osseospeed TX Profile Implant is substantially equivalent in indication and design principles to Astra Tech's Osseospeed TX Profile Implant cleared under K#080156 and The Atlantis Abutment in Zirconia for Astra Implants cleared under K#071946 which has been determined by FDA to be substantia… | 2008 |
| * | K071946 | Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra ImplantsSummary page 4…sseospeed TX Profile Implant is substantially equivalent to Astra Tech's Osseospeed TX Profile System (1(080156) and the Atlantis Abutment in Zirconia for Astra Implant (K071946) predicate devices based on noted similarities in indication, manufacturing material, generated design principle and performance… | 2007 |
What descends from it? (19)
See all 191 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130999 | Osseospeed Profile EV | 2013 | 18 |
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 18 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- None of the 22 ancestors has a recall.
- Of its descendants, K130999 (Dentsply Implants Manufacturing GmbH, 2013) has gone furthest, with 18 descendants of its own.
- 5 other devices also cite its predicate K080156.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 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 prosthesis, in the mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. This device is compatible with the following manufacturers'…
Read the full statement (138 words)
The Atlantis 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 prosthesis, in the mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
This device is compatible with the following manufacturers' implant systems:
The Atlantis Abutment in Zirconia is compatible with the Astra Tech Osseospeed TX Profile 4.5, 5.0 and 5.0 S Implants.
Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.
Highly angled abutments on small diameter implants are intended for the anterior region of the mouth only.
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/K103759 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103759: Atlantis Abutment in Zirconia for Osseospeed TX Profile Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103759
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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