510(k) · Cleared
ClearedAtlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis Gemeini + Abutment in Zirconia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atlantis Components, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Oct 14, 2005 as substantially equivalent to K042658 (Nobel Biocare Uas, Inc., 2004) after a 74-day review. Its family tree reaches back 7 generations to 1995. 261 later devices descend from it.
- Decided
- Oct 14, 2005
- Review
- 74 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K944964 (1995). 39 ancestors in all, the oldest K871863 (1987). 261 later devices descend from it, 7 citing it directly.
- Root · 7 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 6 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 5 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 4 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 3 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 2 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- 1 generation backK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
- This deviceK052070 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia…Atlantis Components, Inc. · 2005
- Descendant · cites it directly · 200 of its ownK093780 Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment…Astra Tech, Inc. · 2010
- Descendant · 2 generations on · 199 of its ownK101004 Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini…Astra Tech, Inc. · 2010
- Descendant · 3 generations on · 197 of its ownK120338 Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later…Astra Tech, Inc. · 2012
- Descendant · 4 generations on · 196 of its ownK120414 Osseospeed PlusAstra Tech AB · 2012
- Descendant · 5 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
Showing 5 of 261 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 261 · See all- K093780Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment, Atlantis Gemini +…Astra Tech, Inc. · 2010 · cites it directly200descendants
- K101004Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis…Astra Tech, Inc. · 2010 · 2 generations on199descendants
- K120338Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in ZirconiaAstra Tech, Inc. · 2012 · 3 generations on197descendants
- K120414Osseospeed PlusAstra Tech AB · 2012 · 4 generations on196descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 5 generations on86descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −6 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −5 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −4 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −3 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −2 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| −1 | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004… | Nobel Biocare Uas, Inc. | 2004 | — |
| 0 (this device) | 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 | — |
| +2 | K101004 | Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment… | Astra Tech, Inc. | 2010 | — |
| +3 | K120338 | Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in… | Astra Tech, Inc. | 2012 | — |
| +4 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| +5 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 8 | 0 |
| 1994 | 7 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 6 | 0 |
| 2015 | 10 | 0 |
| 2016 | 11 | 0 |
| 2017 | 11 | 0 |
| 2018 | 10 | 0 |
| 2019 | 16 | 0 |
| 2020 | 19 | 0 |
| 2021 | 14 | 0 |
| 2022 | 24 | 0 |
| 2023 | 28 | 0 |
| 2024 | 34 | 0 |
| 2025 | 34 | 0 |
| 2026 | 20 | 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 |
|---|---|---|---|
| * | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Summary page 1…(Predicate Device) Manufacturer jD -evice I510(k Number Nobel Biocare Procera Abutment Branemark, Models K042658 10-4001, 1040 4. Description of the Device The devices covered in this submission are abutments… | 2004 |
What descends from it? (261)
See all 2617 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093780 | Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment, Atlantis Gemini +… | 2010 | 200 |
| K062277 | Atlantis Abutment in Zirconia for Nobel Biocare Replace | 2006 | 71 |
| K091920 | Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel Replace Implants… | 2009 | 40 |
| K063734 | Atlantis Abutment in Zirconia for 3I Certain Interface | 2007 | 38 |
| K083871 | Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment… | 2009 | 4 |
| K053450 | Atlantis Abutment for Zimmer Interface | 2006 | 2 |
| K090976 | Vericore Abutment in Zirconia for Implant Systems | 2009 | 1 |
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 10 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 5 of the 39 ancestors have a recall of any class.
- Of its descendants, K093780 (Astra Tech, Inc., 2010) has gone furthest, with 200 descendants of its own.
- 9 other devices also cite its predicate K042658.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 as an accessory to 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 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 (122 words)
The Atlantis Abutment is intended for use as an accessory to 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 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 having an external hex with fiat-to-flat dimensions of 2.7mm or greater: Nobel Biocare, 3i, Lifecore, Sterngold ImplaMed, Innova, and BioHorizons. 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052070 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052070: Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis Gemeini + Abutment in Zirconia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052070
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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