510(k) · Cleared
ClearedAtlantis, Gemini and Gemini+ Abutments in Zirconia for Astra Implants
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 5, 2007 as substantially equivalent to K070833 (Atlantis Components, Inc., 2007) and 2 other predicates after an 84-day review. Its family tree reaches back 5 generations to 1993. 209 later devices descend from it.
- Decided
- Oct 5, 2007
- Review
- 84 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K925765 (1993). 20 ancestors in all. 209 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 4 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 3 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 2 generations backK062069 Atlantis Abutment for 3I Micromini ImplantAtlantis Components, Inc. · 2007
- 1 generation backK070833 Atlantis Abutment for Astra ImplantAtlantis Components, Inc. · 2007
- This deviceK071946 Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra ImplantsAtlantis Components, Inc. · 2007
- Descendant · cites it directly · 202 of its ownK110356 Atlantis Crown Abutment, Atlantis Gemini +(TM) AbutmentAstra Tech, Inc. · 2011
- Descendant · cites it directly · 200 of its ownK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- Descendant · cites it directly · 198 of its ownK101005 Astra Tech Implant System, New ComponentAstra Tech AB · 2011
- Descendant · 2 generations on · 196 of its ownK120414 Osseospeed PlusAstra Tech AB · 2012
- Descendant · 3 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
Showing 5 of 209 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 209 · See all- K110356Atlantis Crown Abutment, Atlantis Gemini +(TM) AbutmentAstra Tech, Inc. · 2011 · cites it directly202descendants
- K112138Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011 · cites it directly200descendants
- K101005Astra Tech Implant System, New ComponentAstra Tech AB · 2011 · cites it directly198descendants
- K120414Osseospeed PlusAstra Tech AB · 2012 · 2 generations on196descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 3 generations on86descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −4 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −3 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −2 | K062069 | Atlantis Abutment for 3I Micromini Implant | Atlantis Components, Inc. | 2007 | — |
| −1 | K070833 | Atlantis Abutment for Astra Implant | Atlantis Components, Inc. | 2007 | — |
| 0 (this device) | K071946 | Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra Implants | Atlantis Components, Inc. | 2007 | — |
| +1 | K110356 | Atlantis Crown Abutment, Atlantis Gemini +(TM) Abutment | Astra Tech, Inc. | 2011 | — |
| +1 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
| +1 | K101005 | Astra Tech Implant System, New Component | Astra Tech AB | 2011 | — |
| +2 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| +3 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 6 | 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? (3)
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 |
|---|---|---|---|
| * | K070833 | Atlantis Abutment for Astra ImplantSummary page 1…510(k) Number Atlantis Components Atlantis Abutment for Astra Implant K070833 Inc. Astra Tech Implant Fixture MicroThreadTM OsseoSpeed TM K053384 Systems Astra Tech Implants Astra Tech Im… | 2007 |
| * | K053384 | Fixature Microthread Osseospeed, a Component of the Astra Tech Implant SystemSummary page 1…Number Atlantis Components Atlantis Abutment for Astra Implant K070833 Inc. Astra Tech Implant Fixture MicroThreadTM OsseoSpeed TM K053384 Systems Astra Tech Implants Astra Tech Implants-Dental System K0241 11 Systems Fixture OsseoSpee… | 2006 |
| * | K024111 | Astra Tech Implants-Dental System Fixture OsseospeedSummary page 1…ant K070833 Inc. Astra Tech Implant Fixture MicroThreadTM OsseoSpeed TM K053384 Systems Astra Tech Implants Astra Tech Implants-Dental System K0241 11 Systems Fixture OsseoSpeed Astra Tech Implants- Dental Systems… | 2003 |
What descends from it? (209)
See all 2095 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110356 | Atlantis Crown Abutment, Atlantis Gemini +(TM) Abutment | 2011 | 202 |
| K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | 2011 | 200 |
| K101005 | Astra Tech Implant System, New Component | 2011 | 198 |
| K103759 | Atlantis Abutment in Zirconia for Osseospeed TX Profile Implant | 2011 | 19 |
| 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 14 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- None of the 20 ancestors has a recall.
- Of its descendants, K110356 (Astra Tech, Inc., 2011) has gone furthest, with 202 descendants of its own.
- 3 other devices also cite its predicate K070833.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 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…
Read the full statement (152 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 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: Astra Tech
Systems OsseoSpeedTM Implants 3.5 mm, 4.0mm, 4.5 mm and 5.0 mm diameters.
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.
Also, highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4
mm are intended for the anterior region of the mouth and are not intended for the
posterior region due to limited strength of the implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071946 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071946: Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071946
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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