510(k) · Cleared
ClearedAtlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant
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 Dec 1, 2011 as substantially equivalent to K111287 (Astra Tech AB, 2011) and 1 other predicate after a 128-day review. Its family tree reaches back 10 generations to 1990. 200 later devices descend from it.
- Decided
- Dec 1, 2011
- Review
- 128 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K894595 (1990). 46 ancestors in all. 200 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations between
- 3 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 2 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 1 generation backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- This deviceK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra 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
Show all 10 generations
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 8 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 7 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 6 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 5 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 4 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 3 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 2 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 1 generation backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- This deviceK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
Showing 5 of 200 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 200 · 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 |
|---|---|---|---|---|---|
| −10 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −9 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −8 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −7 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −6 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −5 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −4 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −3 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −2 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −1 | K111287 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| 0 (this device) | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | 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 |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 3 | 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 30.6 · 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 |
|---|---|---|---|
| * | K111287 | Astra Tech Implant System Cleared while this submission was under review Summary page 3…antial Equivalence: The AtlantiTM Abutment in Zirconia for Astra Tech Osseospeed Plus Implant is substantially equivalent to Astra Tech's Implant System (Osseospeed) K# 111287 and the AtlantisTM Abutment in Zirconia for Astra Implants cleared under K#071946 predicate devices, based on noted similarities… | 2011 |
| * | K071946 | Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra ImplantsSummary page 2…ally equivalent in indication and design principles to the abutment in Astra Tech's Implant System K#1 11287 and the AtlantisTh Abutment in Zirconia for Astra Implants K#071946 which has been determined by FDA to be substantially equivalent to preamendment devices. Premarket Notification S… | 2007 |
What descends from it? (200)
See all 2003 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 21 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 46 ancestors have a recall of any class.
- Of its descendants, K120414 (Astra Tech AB, 2012) has gone furthest, with 196 descendants of its own.
- 2 other devices also cite its predicate K111287.
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 (140 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' implant systems:
The Atlantis Abutment in Zirconia for Astra Tech Osseospeed Implant is compatible with the Astra Tech Osseospeed Plus 3.6mm and 4.2mm 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/K112138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112138: Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112138
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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