510(k) · Cleared
Cleared3I Patient-Specific Overdenture Bar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implant Innovations, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Mar 24, 2004 as substantially equivalent to K974150 (Nobel Biocare Uas, Inc., 1998) after an 86-day review. Its family tree reaches back 5 generations to 1995. 15 later devices descend from it.
- Decided
- Mar 24, 2004
- Review
- 86 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K944964 (1995). 20 ancestors in all, the oldest K910611 (1991). 15 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 4 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 3 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 2 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 1 generation backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- This deviceK034035 3I Patient-Specific Overdenture BarImplant Innovations, Inc. · 2004
- Descendant · cites it directly · 14 of its ownK080864 Cam Structsure Precision Milled BarsBiomet 3i, Inc. · 2008
- Descendant · 2 generations on · 9 of its ownK180998 BioHorizons CAD/CAM BarsBioHorizons Implant Systems, Inc. · 2018
- Descendant · 3 generations on · 8 of its ownK203252 Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc. · 2021
- Descendant · 4 generations on · 3 of its ownK213106 BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl. · 2022
- Descendant · 4 generations on · 2 of its ownK240187 Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc. · 2024
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K080864Cam Structsure Precision Milled BarsBiomet 3i, Inc. · 2008 · cites it directly14descendants
- K180998BioHorizons CAD/CAM BarsBioHorizons Implant Systems, Inc. · 2018 · 2 generations on9descendants
- K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc. · 2021 · 3 generations on8descendants
- K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl. · 2022 · 4 generations on3descendants
- K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc. · 2024 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −4 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −3 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −2 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −1 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| 0 (this device) | K034035 | 3I Patient-Specific Overdenture Bar | Implant Innovations, Inc. | 2004 | — |
| +1 | K080864 | Cam Structsure Precision Milled Bars | Biomet 3i, Inc. | 2008 | — |
| +2 | K180998 | BioHorizons CAD/CAM Bars | BioHorizons Implant Systems, Inc. | 2018 | — |
| +3 | K203252 | Multi-unit Abutments for CONELOG | BioHorizons Implant Systems, Inc. | 2021 | — |
| +4 | K213106 | BTI Interna Dental Implant System UnicCa - Prosthetic Components | B.T.I. Biotechnology Institute, Sl. | 2022 | — |
| +4 | K240187 | Tapered Pro Conical Implant System | BioHorizons Implant Systems, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 8 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 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 30.7 · 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? (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 |
|---|---|---|---|
| * | K974150 | Procera Preparable Abutment SystemSummary page 1…tal laboratories. Predicate device includes: K974150 Nobel Biocare, Inc. Procera® Preparable Abutmen… | 1998 |
| * | — | Hader overdenture bars Named without a submission number | |
| * | — | Dolder overdenture bars Named without a submission number | |
| * | — | Primary overdenture bars Named without a submission number |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080864 | Cam Structsure Precision Milled Bars | 2008 | 14 |
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 9 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K080864 (Biomet 3i, Inc., 2008) has gone furthest, with 14 descendants of its own.
- 4 other devices also cite its predicate K974150.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 3i Patient-Specific Overdenture Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in an edentulous or partially edentulous patient. It is intended for use to support multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be screwed retained.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K034035 · printed Nov 4, 2026
Cite this page
510(k) Report. “K034035: 3I Patient-Specific Overdenture Bar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K034035
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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