510(k) · Cleared
ClearedAtlantis Abutment in Zirconia for 3I Certain Interface
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atlantis Components, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Mar 2, 2007 as substantially equivalent to K981858 (Atlantis Components, Inc., 1999) and 2 other predicates after a 74-day review. Its family tree reaches back 8 generations to 1995. 38 later devices descend from it.
- Decided
- Mar 2, 2007
- Review
- 74 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K944964 (1995). 52 ancestors in all, the oldest K871863 (1987). 38 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 7 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 6 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 5 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 4 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 3 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- 2 generations backK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
- 1 generation backK052070 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia…Atlantis Components, Inc. · 2005
- This deviceK063734 Atlantis Abutment in Zirconia for 3I Certain InterfaceAtlantis Components, Inc. · 2007
- Descendant · cites it directly · 28 of its ownK072483 Atlantis Abutment in Zirconia for 3I Certain Microamini Implants…Atlantis Components, Inc. · 2007
- Descendant · 2 generations on · 27 of its ownK083480 Inclusive Zirconia Abutment BlanksInclusive Dental Solutions · 2009
- Descendant · 3 generations on · 25 of its ownK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
- Descendant · 4 generations on · 14 of its ownK140440 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014
- Descendant · 5 generations on · 7 of its ownK151909 Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K072483Atlantis Abutment in Zirconia for 3I Certain Microamini Implants, Gemini Abutment in…Atlantis Components, Inc. · 2007 · cites it directly28descendants
- K083480Inclusive Zirconia Abutment BlanksInclusive Dental Solutions · 2009 · 2 generations on27descendants
- K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014 · 3 generations on25descendants
- K140440Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014 · 4 generations on14descendants
- K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −7 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −6 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −5 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −4 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −3 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| −2 | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004… | Nobel Biocare Uas, Inc. | 2004 | — |
| −1 | K052070 | Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis… | Atlantis Components, Inc. | 2005 | — |
| 0 (this device) | K063734 | Atlantis Abutment in Zirconia for 3I Certain Interface | Atlantis Components, Inc. | 2007 | — |
| +1 | K072483 | Atlantis Abutment in Zirconia for 3I Certain Microamini Implants, Gemini… | Atlantis Components, Inc. | 2007 | — |
| +2 | K083480 | Inclusive Zirconia Abutment Blanks | Inclusive Dental Solutions | 2009 | — |
| +3 | K132125 | A.B. Dental Devices Dental Implants System | A.B. Dental Devices, Ltd. | 2014 | — |
| +4 | K140440 | Noris Medical Dental Implants System | Noris Medical, Ltd. | 2014 | — |
| +5 | K151909 | Noris Medical Zygomatic Dental Implant System | Noris Medical, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 9 | 0 |
| 1994 | 7 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 30.7 · 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 |
|---|---|---|---|
| * | K981858 | Atlantis Abutment and Atlantis Abutment ScrewSummary page 1…510(k) Number Atlantis Components Atlantis Abutment and Abutment K981858 Inc. Screw 3i Implant Innovations Osseotite NT Certain Dental Implants K031475 Atlantis Components… | 1999 |
| * | K031475 | Osseotite NT Certain ImplantsSummary page 1…s Components Atlantis Abutment and Abutment K981858 Inc. Screw 3i Implant Innovations Osseotite NT Certain Dental Implants K031475 Atlantis Components Atlantis Abutment in Zirconia K052070 Inc. 4. Description of the Device The devices c… | 2003 |
| * | K052070 | Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis Gemeini +…Summary page 1…Screw 3i Implant Innovations Osseotite NT Certain Dental Implants K031475 Atlantis Components Atlantis Abutment in Zirconia K052070 Inc. 4. Description of the Device The devices covered in this submission are abutments which are placed into the dental imp… | 2005 |
What descends from it? (38)
See all 384 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 12 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 6 of the 52 ancestors have a recall of any class.
- Of its descendants, K072483 (Atlantis Components, Inc., 2007) has gone furthest, with 28 descendants of its own.
- 9 other devices also cite its predicate K981858.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 as an accessory to 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 3i OsseotiteTM NT…
Read the full statement (151 words)
The Atlantis Abutment is intended for use as an accessory to 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 3i OsseotiteTM NT Certain Tm (tapered wall) Implants
with 4.0mm, 5.0mm and 6.0mm diameters.
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.
Also, 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/K063734 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063734: Atlantis Abutment in Zirconia for 3I Certain Interface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063734
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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