510(k) · Cleared
ClearedAtlantis Abutment, Atlantis Gemini Abutment, Atlantis Gemini+ Abutment
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 Jul 22, 2005 as substantially equivalent to K981858 (Atlantis Components, Inc., 1999) after a 31-day review. Its family tree reaches back 2 generations to 1994. 19 later devices descend from it.
- Decided
- Jul 22, 2005
- Review
- 31 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K931468 (1994). 3 ancestors in all. 19 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK931468 Restore Hex Cylinder Endosseous SystemLifecore Biomedical, Inc. · 1994
- 1 generation backK981858 Atlantis Abutment and Atlantis Abutment ScrewAtlantis Components, Inc. · 1999
- This deviceK051652 Atlantis Abutment, Atlantis Gemini Abutment, Atlantis Gemini+ AbutmentAtlantis Components, Inc. · 2005
- 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 |
|---|---|---|---|---|---|
| −2 | K931468 | Restore Hex Cylinder Endosseous System | Lifecore Biomedical, Inc. | 1994 | — |
| −1 | K981858 | Atlantis Abutment and Atlantis Abutment Screw | Atlantis Components, Inc. | 1999 | — |
| 0 (this device) | K051652 | Atlantis Abutment, Atlantis Gemini Abutment, Atlantis Gemini+ Abutment | Atlantis Components, Inc. | 2005 | — |
| +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 |
|---|---|---|
| 1995 | 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? (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 |
|---|---|---|---|
| * | K981858 | Atlantis Abutment and Atlantis Abutment ScrewSummary page 1…redicateDevice) Manufacturer Device 510(k) Number Atlantis Components Atlantis Abutment and Abutment K981858 Inc. Screw 4. Description of the Device The devices covered in this submission are abutments which a… | 1999 |
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 11 years and passes through 2 companies; a new generation was cleared every 6.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K130999 (Dentsply Implants Manufacturing GmbH, 2013) has gone furthest, with 18 descendants of its own.
- 9 other devices also cite its predicate K981858.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051652 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051652: Atlantis Abutment, Atlantis Gemini Abutment, Atlantis Gemini+ Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051652
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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