510(k) · Cleared
ClearedAtlantis Abutment for Zimmer Interface
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 Jun 30, 2006 as substantially equivalent to K981858 (Atlantis Components, Inc., 1999) and 1 other predicate after a 207-day review. Its family tree reaches back 2 generations to 1994. 13 later devices descend from it.
- Decided
- Jun 30, 2006
- Review
- 207 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K931468 (1994). 4 ancestors in all. 13 later devices descend from it, 5 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 deviceK053373 Atlantis Abutment for Zimmer InterfaceAtlantis Components, Inc. · 2006
- Descendant · cites it directly · 7 of its ownK072241 Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc. · 2007
- Descendant · 2 generations on · 3 of its ownK103339 TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd. · 2011
- Descendant · cites it directly · 3 of its ownK073258 Atlantis Abutment for Biohorizon Implants, Atlantis Gemini Abutment…Atlantis Components, Inc. · 2008
- Descendant · 2 generations on · 2 of its ownK110778 Biodenta Customized AbutmentBiodenta Swiss AG · 2011
- Descendant · 3 generations on · 1 of its ownK151295 Biodenta Customized Abutment - TitaniumBiodenta Swiss AG · 2015
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K072241Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc. · 2007 · cites it directly7descendants
- K103339TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd. · 2011 · 2 generations on3descendants
- K073258Atlantis Abutment for Biohorizon Implants, Atlantis Gemini Abutment for Biohorizon…Atlantis Components, Inc. · 2008 · cites it directly3descendants
- K110778Biodenta Customized AbutmentBiodenta Swiss AG · 2011 · 2 generations on2descendants
- K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG · 2015 · 3 generations on1descendant
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) | K053373 | Atlantis Abutment for Zimmer Interface | Atlantis Components, Inc. | 2006 | — |
| +1 | K072241 | Primaconnex Cad/Cam Abutment System | Lifecore Biomedical, Inc. | 2007 | — |
| +2 | K103339 | TDS Abutment for Friadent Xive | Pou YU Biotechnology Co., Ltd. | 2011 | — |
| +1 | K073258 | Atlantis Abutment for Biohorizon Implants, Atlantis Gemini Abutment for… | Atlantis Components, Inc. | 2008 | — |
| +2 | K110778 | Biodenta Customized Abutment | Biodenta Swiss AG | 2011 | — |
| +3 | K151295 | Biodenta Customized Abutment - Titanium | Biodenta Swiss AG | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2024 | 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 30.7 · 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 |
|---|---|---|---|
| * | K981858 | Atlantis Abutment and Atlantis Abutment ScrewSummary page 1…510(k) Number Atlantis Components Atlantis Abutment and Abutment K981858 Inc. Screw K011028 Sulzer Dental (Zimmer) Screw-Vent Implant System… | 1999 |
| * | K011028 | Screw-Vent Dental Implant SystemSummary page 1…Number Atlantis Components Atlantis Abutment and Abutment K981858 Inc. Screw K011028 Sulzer Dental (Zimmer) Screw-Vent Implant System 4. Description of the Device The devices covered in this submission… | 2001 |
What descends from it? (13)
See all 135 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072241 | Primaconnex Cad/Cam Abutment System | 2007 | 7 |
| K073258 | Atlantis Abutment for Biohorizon Implants, Atlantis Gemini Abutment for Biohorizon… | 2008 | 3 |
| K103234 | GC Aadva BO AC Abutments | 2011 | 1 |
| K073540 | Atlantis Abutment in Zirconia for Biohorizons Implant | 2008 | 1 |
| K113816 | GC Aadva Abutment- Zirconium-BO AC BH SV | 2013 | 0 |
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 12 years and passes through 2 companies; a new generation was cleared every 7.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K072241 (Lifecore Biomedical, Inc., 2007) has gone furthest, with 7 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. Please note: This device may be used in an early load…
Read the full statement (131 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.
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 umm are intended for the anterior region of the mouth and are not intended for the posterior region due to the limited strength of the implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053373 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053373: Atlantis Abutment for Zimmer Interface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053373
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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