510(k) · Cleared
ClearedAtlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment, Atlantis Gemini + Straumann Bone
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 Apr 15, 2009 as substantially equivalent to K053088 (Institut Straumann AG, 2006) and 4 other predicates after a 107-day review. Its family tree reaches back 9 generations to 1990. 4 later devices descend from it.
- Decided
- Apr 15, 2009
- Review
- 107 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K894595 (1990). 89 ancestors in all, the oldest K871863 (1987). 4 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 2 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 1 generation backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- This deviceK083871 Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann…Astra Tech, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK103234 GC Aadva BO AC AbutmentsGC America, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK141970 Digitek Titanium AbutmentDigitek Dental Solutions Limited · 2015
- Descendant · cites it directly · 0 of its ownK130216 Atlantis Straumann Bone Level AbutmentDentsply Implant · 2013
- Descendant · cites it directly · 0 of its ownK113816 GC Aadva Abutment- Zirconium-BO AC BH SVGC America, Inc. · 2013
Show all 9 generations
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 7 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 6 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 5 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 4 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 3 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 2 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 1 generation backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- This deviceK083871 Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann…Astra Tech, Inc. · 2009
Most influential descendants
Showing 4 of 4 · See all- K103234GC Aadva BO AC AbutmentsGC America, Inc. · 2011 · cites it directly1descendant
- K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited · 2015 · 2 generations on0descendants
- K130216Atlantis Straumann Bone Level AbutmentDentsply Implant · 2013 · cites it directly0descendants
- K113816GC Aadva Abutment- Zirconium-BO AC BH SVGC America, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −8 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −7 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −6 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −5 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −4 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −3 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −2 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| −1 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
| 0 (this device) | K083871 | Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level… | Astra Tech, Inc. | 2009 | — |
| +1 | K103234 | GC Aadva BO AC Abutments | GC America, Inc. | 2011 | — |
| +2 | K141970 | Digitek Titanium Abutment | Digitek Dental Solutions Limited | 2015 | — |
| +1 | K130216 | Atlantis Straumann Bone Level Abutment | Dentsply Implant | 2013 | — |
| +1 | K113816 | GC Aadva Abutment- Zirconium-BO AC BH SV | GC America, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 10 | 0 |
| 1994 | 10 | 0 |
| 1995 | 6 | 0 |
| 1996 | 9 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 6 | 0 |
| 2000 | 2 | 0 |
| 2001 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 7 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 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? (5)
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 |
|---|---|---|---|
| * | K053088 | Slactive ImplantsSummary page 1…__ __ __ __ __ __ __ __ __ __ __ N u m b er Institut Straumann AG SLactive Implants K053088 Institut Straumann AG P.0004 Implants K062 129 Institut Strau… | 2006 |
| * | K062129 | P.0004 ImplantsSummary page 1…Implants K053088 Institut Straumann AG P.0004 Implants K062 129 Institut Straumann AG Straumann Narrow Neck K060958 Atlantis Compon… | 2006 |
| * | K060958 | Straumann Narrow Neck ImplantsSummary page 1…lants K062 129 Institut Straumann AG Straumann Narrow Neck K060958 Atlantis Components AtlantiSTm Abutment for Straumannm K050052 Inc. (currently… | 2006 |
| * | K050052 | Atlantis Abutment for Straumann InterfaceSummary page 1…Narrow Neck K060958 Atlantis Components AtlantiSTm Abutment for Straumannm K050052 Inc. (currently Astra Interface Tech Inc.) Atlantis Components AtlantisTm Abutment in Zirconia… | 2005 |
| * | K052070 | Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis Gemeini +…Summary page 1…50052 Inc. (currently Astra Interface Tech Inc.) Atlantis Components AtlantisTm Abutment in Zirconia K052070 Inc. (currently Astra Tech Inc.) Pre-market Page - 000010 4. Description of the Device The devices cove… | 2005 |
What descends from it? (4)
3 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 19 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 9 of the 89 ancestors have a recall of any class.
- Of its descendants, K103234 (GC America, Inc., 2011) has gone furthest, with 1 descendant of its own.
- 9 other devices also cite its predicate K053088.
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 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 (172 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:
The titanium abutments are compatible with the Straumann Implants: Standard SLActive 3.3mm, 4.1mm and 4.8mm and the Straumann Narrow Neck 3.5mm
The abutments in zirconia are compatible with the Straumann Implants: SLActive 4.1mm and 4.8mm.
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/K083871 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083871: Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment, Atlantis Gemini + Straumann Bone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083871
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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