510(k) · Cleared
ClearedAtlantis Isus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply International, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Feb 19, 2016 as substantially equivalent to K122424 (Dentsply International, Inc., 2013) and 3 other predicates after a 266-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Feb 19, 2016
- Review
- 266 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K944964 (1995). 89 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.
- Root · 9 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 5 generations between
- 3 generations backK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
- 2 generations backK090069 Procera Implant Bridge OverdentureNobel Biocare AB · 2009
- 1 generation backK122424 Isus Implant SuprastructuresDentsply International, Inc. · 2013
- This deviceK151439 Atlantis IsusDentsply International, Inc. · 2016
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 backK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
- 2 generations backK090069 Procera Implant Bridge OverdentureNobel Biocare AB · 2009
- 1 generation backK122424 Isus Implant SuprastructuresDentsply International, Inc. · 2013
- This deviceK151439 Atlantis IsusDentsply International, Inc. · 2016
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 | K043042 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | Nobel Biocare AB | 2004 | — |
| −2 | K090069 | Procera Implant Bridge Overdenture | Nobel Biocare AB | 2009 | — |
| −1 | K122424 | Isus Implant Suprastructures | Dentsply International, Inc. | 2013 | — |
| 0 (this device) | K151439 | Atlantis Isus | Dentsply International, Inc. | 2016 | — |
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 | 11 | 0 |
| 1994 | 9 | 0 |
| 1995 | 7 | 0 |
| 1996 | 10 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 8 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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 30.6 · 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 |
|---|---|---|---|
| * | K122424 | Isus Implant SuprastructuresSummary page 4…The subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices. The primary predicate device is K122424. Predicate Device Name 510(k) Company Name ISUS Implant Suprastructures (Primary Predicate Device) Procera Implant Bridge Over… | 2013 |
| * | K090069 | Procera Implant Bridge OverdentureSummary page 4…te Device) Procera Implant Bridge Overdenture ANKYLOS SynCone Abutment 5° NobelProcera Angulated Screw Channel Abutment Replace K122424 | DENTSPLY International Inc. K090069 | Nobel Biocare USA, LLC K131644 | DENTSPLY International Inc. K133377 | Nobel Biocare USA, LLC 4. Description of Device: ATL… | 2009 |
| * | K131644 | Ankylos Syncone Abutment 5(Degree)Summary page 4…Overdenture ANKYLOS SynCone Abutment 5° NobelProcera Angulated Screw Channel Abutment Replace K122424 | DENTSPLY International Inc. K090069 | Nobel Biocare USA, LLC K131644 | DENTSPLY International Inc. K133377 | Nobel Biocare USA, LLC 4. Description of Device: ATLANTIS™ [SUS is a custom restorativ… | 2014 |
| * | K133377 | Nobelprocera Angulated Screw Channel Abutment ReplaceSummary page 4…° NobelProcera Angulated Screw Channel Abutment Replace K122424 | DENTSPLY International Inc. K090069 | Nobel Biocare USA, LLC K131644 | DENTSPLY International Inc. K133377 | Nobel Biocare USA, LLC 4. Description of Device: ATLANTIS™ [SUS is a custom restorative device that is intended to be attache… | 2014 |
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 21 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 9 of the 89 ancestors have a recall of any class.
- 3 other devices also cite its predicate K122424.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
ATLANTIS™ ISUS implant suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. ATLANTIS™ ISUS implant suprastructures are intended for attachment to a minimum of two (2) implants and are indicated for compatibility with the following implant and abutment systems: Implants: 3i Internal Connection: D3.4, D4.1, D5, D6 Friadent XiVE S…
Read the full statement (186 words)
ATLANTIS™ ISUS implant suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
ATLANTIS™ ISUS implant suprastructures are intended for attachment to a minimum of two (2) implants and are indicated for compatibility with the following implant and abutment systems:
Implants:
3i Internal Connection: D3.4, D4.1, D5, D6
Friadent XiVE S: D3.0, D3.4, D3.8, D4.5, D5.5
Nobel Biocare Active Internal: NP (3.5mm), RP (4.3mm, 5.0mm)
Nobel Biocare Replace Select: NP (3.5mm), RP (4.3mm), WP (5.0mm) and Replace Select 6.0mm
Straumann Bone Level: NC (3.3mm), RC (4.lmm, 4.8mm)
Straumann NN (3.5mm), RN (4.8mm), WN (6.0mm)
Zimmer Screw Vent: D3.5, D4.5, D5.7
Abutments:
3i Low Profile Abutment
ANKYLOS Balance Base Abutment D5.5 and Narrow Abutment D4.2
ASTRA TECH 20° and 45° UniAbutment
Astra Tech UniAbutment EV 3.6
Friadent XiVE MP D3.8, D4.5, D5.5
Friadent XiVE TG D3.8,D 4.5, D5.5
Nobel Biocare Multi-Unit Abutment RP: 4.0 mm
Straumann Bone Level Angled Abutment: 4.0 mm
Straumann Bone Level: Multi-Base Abutment D3.5, D4.5
Straumann RN (4.8 mm), WN (6.5 mm)
Zimmer Tapered Abutment: 4.5 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/K151439 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151439: Atlantis Isus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151439
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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