510(k) · Cleared
ClearedAtlantis Straumann Bone Level Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Implant · NHA Abutment, Implant, Dental, Endosseous
Cleared on May 1, 2013 as substantially equivalent to K083871 (Astra Tech, Inc., 2009) and 3 other predicates after a 92-day review. Its family tree reaches back 10 generations to 1990.
- Decided
- May 1, 2013
- Review
- 92 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K894595 (1990). 101 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations between
- 3 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 2 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 1 generation backK083871 Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann…Astra Tech, Inc. · 2009
- This deviceK130216 Atlantis Straumann Bone Level AbutmentDentsply Implant · 2013
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 backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 7 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 6 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 5 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 4 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 3 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 2 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 1 generation backK083871 Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann…Astra Tech, Inc. · 2009
- This deviceK130216 Atlantis Straumann Bone Level AbutmentDentsply Implant · 2013
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 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −7 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −6 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −5 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −4 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −3 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| −2 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
| −1 | K083871 | Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level… | Astra Tech, Inc. | 2009 | — |
| 0 (this device) | K130216 | Atlantis Straumann Bone Level Abutment | Dentsply Implant | 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 | 7 | 0 |
| 1996 | 9 | 0 |
| 1997 | 3 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 5 | 0 |
| 2003 | 7 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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? (4)
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 |
|---|---|---|---|
| * | K083871 | Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment…Summary page 2…butment is substantially equivalent in indications and design principles to the following legally marketed predicate devices: AtlantisTM Straumann Bone Level Abutment - K083871I AtlantiSTM Crown Abutment in Zirconia - KI 110356 Straumann Dental Implant System - K083550 13.004 Implants - K062 129 Non-clin… | 2009 |
| * | K110356 | Atlantis Crown Abutment, Atlantis Gemini +(TM) AbutmentSummary page 2…nd design principles to the following legally marketed predicate devices: AtlantisTM Straumann Bone Level Abutment - K083871I AtlantiSTM Crown Abutment in Zirconia - KI 110356 Straumann Dental Implant System - K083550 13.004 Implants - K062 129 Non-clinical testing data submitted, referenced, or relied… | 2011 |
| * | K083550 | Straumann Dental Implant SystemSummary page 2…ally marketed predicate devices: AtlantisTM Straumann Bone Level Abutment - K083871I AtlantiSTM Crown Abutment in Zirconia - KI 110356 Straumann Dental Implant System - K083550 13.004 Implants - K062 129 Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalenc… | 2009 |
| * | K062129 | P.0004 ImplantsSummary page 2…vices: AtlantisTM Straumann Bone Level Abutment - K083871I AtlantiSTM Crown Abutment in Zirconia - KI 110356 Straumann Dental Implant System - K083550 13.004 Implants - K062 129 Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: engineering ana… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 9 of the 101 ancestors have a recall of any class.
- 2 other devices also cite its predicate K083871.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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. The Atlantis Crown Abutment is intended for use with an…
Read the full statement (125 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.
The Atlantis Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous patients. The abutment screw is intended to secure the crown abutment to the endosseous implant.
Atlantis Straumann Bone Level Abutment in Zirconia is compatible with the 03.3 mm Straumann Bone Level Implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130216 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130216: Atlantis Straumann Bone Level Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130216
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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