510(k) · Cleared
ClearedAtlantis Crown Abutment, Atlantis Gemini +(TM) 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 Jun 10, 2011 as substantially equivalent to K071946 (Atlantis Components, Inc., 2007) after a 123-day review. Its family tree reaches back 6 generations to 1993. 202 later devices descend from it.
- Decided
- Jun 10, 2011
- Review
- 123 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K925765 (1993). 21 ancestors in all. 202 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 5 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 4 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 3 generations backK062069 Atlantis Abutment for 3I Micromini ImplantAtlantis Components, Inc. · 2007
- 2 generations backK070833 Atlantis Abutment for Astra ImplantAtlantis Components, Inc. · 2007
- 1 generation backK071946 Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra ImplantsAtlantis Components, Inc. · 2007
- This deviceK110356 Atlantis Crown Abutment, Atlantis Gemini +(TM) AbutmentAstra Tech, Inc. · 2011
- Descendant · cites it directly · 196 of its ownK120414 Osseospeed PlusAstra Tech AB · 2012
- Descendant · 2 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · 3 generations on · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- Descendant · 2 generations on · 42 of its ownK150295 LOCATOR RTxZest Anchors, Inc. · 2015
- Descendant · 3 generations on · 38 of its ownK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
Showing 5 of 202 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 202 · See all- K120414Osseospeed PlusAstra Tech AB · 2012 · cites it directly196descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 2 generations on86descendants
- K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · 3 generations on51descendants
- K150295LOCATOR RTxZest Anchors, Inc. · 2015 · 2 generations on42descendants
- K191986DESS Dental Smart SolutionsTerrats Medical SL · 2019 · 3 generations on38descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −5 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −4 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −3 | K062069 | Atlantis Abutment for 3I Micromini Implant | Atlantis Components, Inc. | 2007 | — |
| −2 | K070833 | Atlantis Abutment for Astra Implant | Atlantis Components, Inc. | 2007 | — |
| −1 | K071946 | Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra Implants | Atlantis Components, Inc. | 2007 | — |
| 0 (this device) | K110356 | Atlantis Crown Abutment, Atlantis Gemini +(TM) Abutment | Astra Tech, Inc. | 2011 | — |
| +1 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| +2 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +3 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| +2 | K150295 | LOCATOR RTx | Zest Anchors, Inc. | 2015 | — |
| +3 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 10 | 0 |
| 2018 | 7 | 0 |
| 2019 | 10 | 0 |
| 2020 | 15 | 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 30.7 · 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? (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 |
|---|---|---|---|
| * | K071946 | Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra ImplantsSummary page 3…s, the AtlantisTh Crown Abutment in Zirconia is substantially equivalent in indications and design principles to the Atlantis~h Abutment for Astra Implants cleared under K071946 which has been determined by FDA to be substantially equivalent to preamendment devices. Premarket Notification S… | 2007 |
What descends from it? (202)
See all 2024 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 18 years and passes through 5 companies; a new generation was cleared every 3.7 years on median.
- None of the 21 ancestors has a recall.
- Of its descendants, K120414 (Astra Tech AB, 2012) has gone furthest, with 196 descendants of its own.
- 4 other devices also cite its predicate K071946.
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 Crown Abutment in Zirconia is intended for use with an endosseus implant to function as a substructure that also serves as the final restoration, in a partilly or completely edentulous patient. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant. This device is compatible with the following manufacturers' implant systems: Astra Tech Microthread ST 3.5mm, 4.0mm, 4.5mm and…
Read the full statement (116 words)
The Atlantis Crown Abutment in Zirconia is intended for use with an endosseus implant to
function as a substructure that also serves as the final restoration, in a partilly or completely
edentulous patient. The prosthesis is screw retained. The abutment screw is intended to secure
the crown abutment to the endosseous implant.
This device is compatible with the following manufacturers' implant systems:
Astra Tech Microthread ST 3.5mm, 4.0mm, 4.5mm and 5.0mmn 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 of the
mouth only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110356 · printed Nov 3, 2026
Cite this page
510(k) Report. “K110356: Atlantis Crown Abutment, Atlantis Gemini +(TM) Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110356
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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