510(k) · Cleared
ClearedAtlantis Abutment for Keystone Implant, 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 Feb 3, 2011 as substantially equivalent to K051614 (Lifecore Biomedical, Inc., 2005) and 1 other predicate after a 114-day review. Its family tree reaches back 11 generations to 1996. 4 later devices descend from it.
- Decided
- Feb 3, 2011
- Review
- 114 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K960026 (1996). 45 ancestors in all, the oldest K894595 (1990). 4 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 7 generations between
- 3 generations backK050506 Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc. · 2005
- 2 generations backK051614 Primaconnex Internal Connection Implant System, Primaconnex Internal…Lifecore Biomedical, Inc. · 2005 · Recalled
- 1 generation backK062876 Primaconnex Ceramic AbutmentsLifecore Biomedical, Inc. · 2006
- This deviceK103020 Atlantis Abutment for Keystone Implant, Atlantis Gemini AbutmentAtlantis Components, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK161713 Dentium CAD/CAM AbutmentsDentium Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK251605 DIMPLO Implant SystemDIMPLO, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK221972 Warantec Custom AbutmentWarantec Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK171622 Dentium Ti-BaseDentium Co., Ltd. · 2018
Show all 11 generations
- Root · 11 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 10 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 9 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 8 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 7 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 5 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 4 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 3 generations backK050506 Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc. · 2005
- 2 generations backK051614 Primaconnex Internal Connection Implant System, Primaconnex Internal…Lifecore Biomedical, Inc. · 2005 · Recalled
- 1 generation backK062876 Primaconnex Ceramic AbutmentsLifecore Biomedical, Inc. · 2006
- This deviceK103020 Atlantis Abutment for Keystone Implant, Atlantis Gemini AbutmentAtlantis Components, Inc. · 2011
Most influential descendants
Showing 4 of 4 · See all- K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd. · 2016 · cites it directly3descendants
- K251605DIMPLO Implant SystemDIMPLO, Ltd. · 2025 · 2 generations on0descendants
- K221972Warantec Custom AbutmentWarantec Co., Ltd. · 2023 · 2 generations on0descendants
- K171622Dentium Ti-BaseDentium Co., Ltd. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −10 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −9 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −8 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −7 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −5 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −4 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −3 | K050506 | Primasolo One-Piece Implants & Healing Caps | Lifecore Biomedical, Inc. | 2005 | — |
| −2 | K051614 | Primaconnex Internal Connection Implant System, Primaconnex Internal… | Lifecore Biomedical, Inc. | 2005 | 5 |
| −1 | K062876 | Primaconnex Ceramic Abutments | Lifecore Biomedical, Inc. | 2006 | — |
| 0 (this device) | K103020 | Atlantis Abutment for Keystone Implant, Atlantis Gemini Abutment | Atlantis Components, Inc. | 2011 | — |
| +1 | K161713 | Dentium CAD/CAM Abutments | Dentium Co., Ltd. | 2016 | — |
| +2 | K251605 | DIMPLO Implant System | DIMPLO, Ltd. | 2025 | — |
| +2 | K221972 | Warantec Custom Abutment | Warantec Co., Ltd. | 2023 | — |
| +2 | K171622 | Dentium Ti-Base | Dentium Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 5 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K051614 | Primaconnex Internal Connection Implant System, Primaconnex Internal Connection…Summary page 2…ne Implant is substantially equivalent in indications and design principles to Lifecore's predicate devices: PrimaConnex Internal Connection Implant System cleared under K05 1614 and Primonnex Ceramic Abutments cleared under K062876, each of which has been determined by FDA to be substantially equivalent to… | 2005 |
| * | K062876 | Primaconnex Ceramic AbutmentsSummary page 2…nd design principles to Lifecore's predicate devices: PrimaConnex Internal Connection Implant System cleared under K05 1614 and Primonnex Ceramic Abutments cleared under K062876, each of which has been determined by FDA to be substantially equivalent to preamendment devices.… | 2006 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161713 | Dentium CAD/CAM Abutments | 2016 | 3 |
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 3 companies; a new generation was cleared every 8 months on median.
- 5 of the 45 ancestors have a recall of any class.
- Of its descendants, K161713 (Dentium Co., Ltd., 2016) has gone furthest, with 3 descendants of its own.
- 10 other devices also cite its predicate K051614.
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 (146 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' im~plant systems:
The titanium abutments are compatible with the Keystone 3.5mm, 4.0mm, 4.1mmu and 5.0mm. Kezstone Implants.
The zirconia abutments are compatible with the Keystone 3.5mm, 4.0mm, 4. 1mm and 5.0min Keystone 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 only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103020: Atlantis Abutment for Keystone Implant, 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/K103020
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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