510(k) · Cleared
ClearedAtlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis Gemini + Abutment
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 Aug 16, 2010 as substantially equivalent to K083805 (Dentsply Intl., Inc., 2009) and 1 other predicate after a 126-day review. Its family tree reaches back 9 generations to 1995. 199 later devices descend from it.
- Decided
- Aug 16, 2010
- Review
- 126 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K944964 (1995). 61 ancestors in all, the oldest K871863 (1987). 199 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 5 generations between
- 3 generations backK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
- 2 generations backK052070 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia…Atlantis Components, Inc. · 2005
- 1 generation backK093780 Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment…Astra Tech, Inc. · 2010
- This deviceK101004 Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini…Astra Tech, Inc. · 2010
- Descendant · cites it directly · 197 of its ownK120338 Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later…Astra Tech, Inc. · 2012
- Descendant · 2 generations on · 196 of its ownK120414 Osseospeed PlusAstra Tech AB · 2012
- Descendant · 3 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · 4 generations on · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- Descendant · 3 generations on · 42 of its ownK150295 LOCATOR RTxZest Anchors, Inc. · 2015
Show all 9 generations
- Root · 9 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 8 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 7 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 6 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 5 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 4 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- 3 generations backK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
- 2 generations backK052070 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia…Atlantis Components, Inc. · 2005
- 1 generation backK093780 Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment…Astra Tech, Inc. · 2010
- This deviceK101004 Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini…Astra Tech, Inc. · 2010
Showing 5 of 199 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 199 · See all- K120338Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in ZirconiaAstra Tech, Inc. · 2012 · cites it directly197descendants
- K120414Osseospeed PlusAstra Tech AB · 2012 · 2 generations on196descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 3 generations on86descendants
- K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · 4 generations on51descendants
- K150295LOCATOR RTxZest Anchors, Inc. · 2015 · 3 generations on42descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −8 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −7 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −6 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −5 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −4 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| −3 | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004… | Nobel Biocare Uas, Inc. | 2004 | — |
| −2 | K052070 | Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis… | Atlantis Components, Inc. | 2005 | — |
| −1 | K093780 | Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment, Atlantis… | Astra Tech, Inc. | 2010 | — |
| 0 (this device) | K101004 | Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment… | Astra Tech, Inc. | 2010 | — |
| +1 | K120338 | Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in… | Astra Tech, Inc. | 2012 | — |
| +2 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| +3 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +4 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| +3 | K150295 | LOCATOR RTx | Zest Anchors, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 10 | 0 |
| 1994 | 9 | 0 |
| 1995 | 4 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 6 | 0 |
| 2016 | 7 | 0 |
| 2017 | 10 | 0 |
| 2018 | 7 | 0 |
| 2019 | 10 | 0 |
| 2020 | 14 | 0 |
| 2021 | 14 | 0 |
| 2022 | 20 | 0 |
| 2023 | 27 | 0 |
| 2024 | 30 | 0 |
| 2025 | 33 | 0 |
| 2026 | 17 | 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 |
|---|---|---|---|
| * | K083805 | Ankylos C/X Dental Implant SystemSummary page 1…510(k) Number Dentsply International, Ankylos C/X Dental Implant System K083805 Inc. Astra Tech Inc. AtlantiSTM Abutmnent for Dentsply K093780 Implant === Page 2… | 2009 |
| * | K093780 | Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment, Atlantis Gemini +… Cleared while this submission was under review Summary page 1…Number Dentsply International, Ankylos C/X Dental Implant System K083805 Inc. Astra Tech Inc. AtlantiSTM Abutmnent for Dentsply K093780 Implant Pre-market Notification Page -000010 4. Description of the Device The… | 2010 |
What descends from it? (199)
See all 1992 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 15 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 7 of the 61 ancestors have a recall of any class.
- Of its descendants, K120338 (Astra Tech, Inc., 2012) has gone furthest, with 197 descendants of its own.
- 7 other devices also cite its predicate K083805.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 cement 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 (154 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 cement 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 titanium abutments are compatible with the Dentsply 3.5mm, 4.5mm, 5.5mm and
7.0mm Ankylos 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 (i.e. 30 degrees) on implants with diameters less than 4 mm are
intended for the anterior region of the mouth and are not intended for the posterior region
due to limited strength of the implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101004: Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis Gemini + Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101004
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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