510(k) · Cleared
ClearedAtlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel Replace Implants, Atlantis Gemini + Abutment for Nobel
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 Sep 28, 2009 as substantially equivalent to K062277 (Atlantis Components, Inc., 2006) and 2 other predicates after a 90-day review. Its family tree reaches back 9 generations to 1995. 40 later devices descend from it.
- Decided
- Sep 28, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K944964 (1995). 51 ancestors in all, the oldest K871863 (1987). 40 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 5 generations between
- 3 generations backK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
- 2 generations backK052070 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia…Atlantis Components, Inc. · 2005
- 1 generation backK062277 Atlantis Abutment in Zirconia for Nobel Biocare ReplaceAtlantis Components, Inc. · 2006
- This deviceK091920 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel…Astra Tech, Inc. · 2009
- Descendant · cites it directly · 30 of its ownK103291 Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011
- Descendant · 2 generations on · 29 of its ownK122295 Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L. · 2013
- Descendant · 3 generations on · 26 of its ownK151621 BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc. · 2016
- Descendant · 4 generations on · 22 of its ownK183518 Preat AbutmentsPreat Corporation · 2019 · Recalled
- Descendant · 5 generations on · 8 of its ownK193096 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020
Show all 9 generations
- Root · 9 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 8 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 7 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 6 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 5 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 4 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- 3 generations backK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
- 2 generations backK052070 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia…Atlantis Components, Inc. · 2005
- 1 generation backK062277 Atlantis Abutment in Zirconia for Nobel Biocare ReplaceAtlantis Components, Inc. · 2006
- This deviceK091920 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel…Astra Tech, Inc. · 2009
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011 · cites it directly30descendants
- K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L. · 2013 · 2 generations on29descendants
- K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc. · 2016 · 3 generations on26descendants
- K183518Preat AbutmentsPreat Corporation · 2019 · 4 generations on22descendants
- K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −8 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −7 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −6 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −5 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −4 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| −3 | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004… | Nobel Biocare Uas, Inc. | 2004 | — |
| −2 | K052070 | Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis… | Atlantis Components, Inc. | 2005 | — |
| −1 | K062277 | Atlantis Abutment in Zirconia for Nobel Biocare Replace | Atlantis Components, Inc. | 2006 | — |
| 0 (this device) | K091920 | Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel Replace… | Astra Tech, Inc. | 2009 | — |
| +1 | K103291 | Biohorizons Laser-Lok Abutments for Nobel Biocare | BioHorizons Implant Systems, Inc. | 2011 | — |
| +2 | K122295 | Core 3D Abutment System for Digital Prosthetic Solutions | Core 3D Protech, S.L. | 2013 | — |
| +3 | K151621 | BioHorizons CAD/CAM Abutments | BioHorizons Implant Systems, Inc. | 2016 | — |
| +4 | K183518 | Preat Abutments | Preat Corporation | 2019 | 3 |
| +5 | K193096 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 9 | 0 |
| 1994 | 9 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 7 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 6 | 0 |
| 2024 | 2 | 0 |
| 2025 | 8 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K062277 | Atlantis Abutment in Zirconia for Nobel Biocare ReplaceSummary page 1…510(k) Number Astra Tech Inc. AtlantisTM Abutment in Zirconia for K062277 (formerly Atlantis Nobel Replace Implant Components Inc.) Nobel Biocare Replace TiUnite… | 2006 |
| * | K023113 | Replace Tiunite Endosseous ImplantSummary page 1…Abutment in Zirconia for K062277 (formerly Atlantis Nobel Replace Implant Components Inc.) Nobel Biocare Replace TiUnite K023113 Astra Tech Inc. Atlantis Abutment in Zirconia K052070 (formerly Atlantis Componens zinc.) Pr… | 2002 |
| * | K052070 | Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis Gemeini +…Summary page 1…ce Implant Components Inc.) Nobel Biocare Replace TiUnite K023113 Astra Tech Inc. Atlantis Abutment in Zirconia K052070 (formerly Atlantis Componens zinc.) Pre-market Page - 000010 4. Description of the Device The devices co… | 2005 |
What descends from it? (40)
See all 402 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 14 years and passes through 5 companies; a new generation was cleared every 12 months on median.
- 7 of the 51 ancestors have a recall of any class.
- Of its descendants, K103291 (BioHorizons Implant Systems, Inc., 2011) has gone furthest, with 30 descendants of its own.
- 4 other devices also cite its predicate K062277.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 and 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 (157 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 and 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: Nobel Replace® Straight Groovy 3.5mm, Nobel Replace® Select Tapered and Straight 3.5mm and NobelSpeedy T m 3.5mm 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 (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/K091920 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091920: Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel Replace Implants, Atlantis Gemini + Abutment for Nobel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091920
Report an extraction error
Are you the manufacturer?
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