510(k) · Cleared
ClearedIsus Implant Suprastructures
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 Jul 5, 2013 as substantially equivalent to K101582 (Biomet 3i, Inc., 2010) and 2 other predicates after a 330-day review. Its family tree reaches back 8 generations to 1995. 13 later devices descend from it.
- Decided
- Jul 5, 2013
- Review
- 330 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K944964 (1995). 63 ancestors in all, the oldest K871863 (1987). 13 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 backK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
- 1 generation backK090069 Procera Implant Bridge OverdentureNobel Biocare AB · 2009
- This deviceK122424 Isus Implant SuprastructuresDentsply International, Inc. · 2013
- Descendant · cites it directly · 5 of its ownK160207 ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016
- Descendant · cites it directly · 4 of its ownK212676 Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical) · 2022
- Descendant · 2 generations on · 4 of its ownK163350 Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona · 2017
- Descendant · 2 generations on · 3 of its ownK221019 Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical) · 2022
- Descendant · 3 generations on · 2 of its ownK233083 Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical) · 2024
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016 · cites it directly5descendants
- K212676Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical) · 2022 · cites it directly4descendants
- K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona · 2017 · 2 generations on4descendants
- K221019Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical) · 2022 · 2 generations on3descendants
- K233083Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical) · 2024 · 3 generations on2descendants
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 | K043042 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | Nobel Biocare AB | 2004 | — |
| −1 | K090069 | Procera Implant Bridge Overdenture | Nobel Biocare AB | 2009 | — |
| 0 (this device) | K122424 | Isus Implant Suprastructures | Dentsply International, Inc. | 2013 | — |
| +1 | K160207 | ATLANTIS ISUS Implant Suprastructures | Dentsply International, Inc. | 2016 | — |
| +1 | K212676 | Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Osteon Medical) | 2022 | — |
| +2 | K163350 | Multibase Abutments EV and ATLANTIS Suprastructures | Dentsply Sirona | 2017 | — |
| +2 | K221019 | Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Aka Osteon Medical) | 2022 | — |
| +3 | K233083 | Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Aka Osteon Medical) | 2024 | — |
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 | 9 | 0 |
| 1994 | 9 | 0 |
| 1995 | 6 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K101582 | Cam Structsure BarsSummary page 1…* Device Class: 11 * Product Code: NHA 5.3 Predicate Device: CAM StrUCtSURE® Overdenture Bar -K 101582- Procera® Implant Bridge Overdenture -K090069 FRIALIT-2® EstheticBase Abutments -K0134… | 2010 |
| * | K090069 | Procera Implant Bridge OverdentureSummary page 1…NHA 5.3 Predicate Device: CAM StrUCtSURE® Overdenture Bar -K 101582- Procera® Implant Bridge Overdenture -K090069 FRIALIT-2® EstheticBase Abutments -K013438 5.4 Description of Device: The ISUS Implant… | 2009 |
| * | K013438 | Frialit-2 Estheticbase AbutmentSummary page 1…® Overdenture Bar -K 101582- Procera® Implant Bridge Overdenture -K090069 FRIALIT-2® EstheticBase Abutments -K013438 5.4 Description of Device: The ISUS Implant Suprastructures are metallic dental restorative devices which… | 2001 |
What descends from it? (13)
See all 134 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 18 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 8 of the 63 ancestors have a recall of any class.
- Of its descendants, K160207 (Dentsply International, Inc., 2016) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K101582.
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 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. The ISUS Implant Suprastructures are intended for attachment to a minimum of two (2) implants. ISUS Implant Suprastructures are indicated for compatibility with the following implant and abutment systems: Implants: * Nobel Biocare Replace Select: NP (3.5mm)…
Read the full statement (204 words)
The 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. The ISUS Implant Suprastructures are intended for attachment to a minimum of two (2) implants.
ISUS Implant Suprastructures are indicated for compatibility with the following implant and abutment systems:
Implants:
* Nobel Biocare Replace Select: NP (3.5mm), RP (4.3mm), WP (5.0mm), and Replace Select 6.0mm
* Nobel Biocare Active Internal: NP (3.5mm), RP (4.3mm, 5.0mm)
* Zimmer Screw Vent: 1D3.5, D4.5, D5.7
* Straumann: NN (3.5mm), RN (4.8mm), WN (6.0mm)
* Straumann Bone Level: NC (3.3mm), RC (4.1 mm, 4.8mm)
* 3i Internal Connection: D3.4, D4.1, D5, D6
* Friadent XiVE S: D3, D3.4, D3.8, D4.5, D5.5
Abutments:
* ASTRA TECH- 200 and 450 UniAbutment
* ASTRA TECH UniAbutment EV: 3.6
* ANKYLOS Balance Base Abutment D5.5 and Narrow Abutment D4.2
* Nobel Biocare Multi-Unit Abutment RP: 4.0 mm
* Zimmer Tapered Abutment: 4.5mm
* Straumann RN(4.8mm), WN (6.5 mm)
* Straumann Bone Level: Multi-Base Abutment D3.5, D4.5
* Straumann Bone Level Angled Abutment: 4.0 mm
* 3i Low Profile Abutment
* Friadent XiVE MP D3.8, D4.5, D5.5
* Friadent XiVE TG D3.8, D4.5, D5.5
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/K122424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122424: Isus Implant Suprastructures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122424
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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