510(k) · Cleared
ClearedATLANTIS Abutment for MIS Conical Connection Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Sirona · NHA Abutment, Implant, Dental, Endosseous
Cleared on Mar 5, 2020 as substantially equivalent to K172225 (Dentsply Sirona, 2017) after a 76-day review. Its family tree reaches back 15 generations to 1990. 3 later devices descend from it.
- Decided
- Mar 5, 2020
- Review
- 76 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K894595 (1990). 161 ancestors in all, the oldest K781060 (1978). 3 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations between
- 3 generations backK130999 Osseospeed Profile EVDentsply Implants Manufacturing GmbH · 2013
- 2 generations backK160626 ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona · 2016
- 1 generation backK172225 Atlantis Abutment for MIS ImplantDentsply Sirona · 2017
- This deviceK193529 ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona · 2020
- Descendant · cites it directly · 2 of its ownK250081 Atlantis® Abutments in TitaniumDentsply Sirona · 2025
- Descendant · 2 generations on · 0 of its ownK252343 Atlantis® Abutments in TitaniumDentsply Sirona · 2025
- Descendant · 2 generations on · 0 of its ownK251205 Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM…Dentsply Sirona · 2025
Show all 15 generations
- Root · 15 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 14 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 13 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 12 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 11 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 10 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 9 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 8 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 7 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 6 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 5 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 4 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
- 3 generations backK130999 Osseospeed Profile EVDentsply Implants Manufacturing GmbH · 2013
- 2 generations backK160626 ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona · 2016
- 1 generation backK172225 Atlantis Abutment for MIS ImplantDentsply Sirona · 2017
- This deviceK193529 ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona · 2020
Most influential descendants
Showing 3 of 3 · See all- K250081Atlantis® Abutments in TitaniumDentsply Sirona · 2025 · cites it directly2descendants
- K252343Atlantis® Abutments in TitaniumDentsply Sirona · 2025 · 2 generations on0descendants
- K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −14 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −13 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −12 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −11 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −10 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −9 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −8 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −7 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −6 | K111287 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −5 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
| −4 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| −3 | K130999 | Osseospeed Profile EV | Dentsply Implants Manufacturing GmbH | 2013 | — |
| −2 | K160626 | ATLANTIS Abutment for HIOSSEN ET implant | Dentsply Sirona | 2016 | — |
| −1 | K172225 | Atlantis Abutment for MIS Implant | Dentsply Sirona | 2017 | — |
| 0 (this device) | K193529 | ATLANTIS Abutment for MIS Conical Connection Implants | Dentsply Sirona | 2020 | — |
| +1 | K250081 | Atlantis® Abutments in Titanium | Dentsply Sirona | 2025 | — |
| +2 | K252343 | Atlantis® Abutments in Titanium | Dentsply Sirona | 2025 | — |
| +2 | K251205 | Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants | Dentsply Sirona | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 11 | 0 |
| 1994 | 10 | 0 |
| 1995 | 10 | 0 |
| 1996 | 11 | 0 |
| 1997 | 6 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 11 | 0 |
| 2003 | 8 | 0 |
| 2004 | 6 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 6 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | K172225 | Atlantis Abutment for MIS ImplantSummary page 5…510(k) Company Name ATLANTIS® Abutment for MIS MIS Implants Technologies LTD K172225 Implant (Dentsply Sirona) Reference Devices: ATLANTIS® Abutment for… | 2017 |
| † | K160626 | ATLANTIS Abutment for HIOSSEN ET implant | 2016 |
| † | K163349 | MIS V3 Conical Connection Dental Implant System | 2017 |
| † | K172505 | MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical… | 2017 |
| † | K112162 | Conical Connection Implants | 2012 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250081 | Atlantis® Abutments in Titanium | 2025 | 2 |
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 30 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 15 of the 161 ancestors have a recall of any class.
- Of its descendants, K250081 (Dentsply Sirona, 2025) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K172225.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the ATLANTIS® Abutment to the endosseous implant. The ATLANTIS® Crown Abutment is intended for use with…
Read the full statement (297 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 mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the ATLANTIS® 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 a partially or completely edentulous patient. The abutment screw is intended to secure the ATLANTIS® Crown Abutment to the endosseous implant.
The ATLANTIS® Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS® Conus Abutment to the endosseous implant.
The ATLANTIS® Healing Abutment can be used with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The abutment screw is intended to secure the ATLANTIS® Healing Abutment to the endosseous implant.
ATLANTIS® Abutment is compatible with MIS Conical Connection implant from MIS Implant System.
ATLANTIS® products are compatible with the implants shown in the table below.
Implant manufacturer - MIS-IMPLANT TECHNOLOGIES INC
Trade Name Abutment Platform Diameter Implant Diameter
Atlantis Abutment for MIS V3 NP 02.765mm V3: ¥3.30 mm
Atlantis Abutment for MIS C1 NP 2. 76mm Cl: @¥3.30 mm
Atlantis Abutment for MIS C1 & V3 SP ©@3.16mm Cl: 93.75,42 mm, V3: ©03.90,4.3,5.0 mm
Atlantis Abutment for MIS C1 WP 04.0Imm Cl: 95.0 mm
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K193529 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193529: ATLANTIS Abutment for MIS Conical Connection Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193529
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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