510(k) · Cleared
ClearedCam Structsure Precision Milled Bars
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet 3i, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jul 21, 2008 as substantially equivalent to K034035 (Implant Innovations, Inc., 2004) after a 115-day review. Its family tree reaches back 6 generations to 1995. 14 later devices descend from it.
- Decided
- Jul 21, 2008
- Review
- 115 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K944964 (1995). 21 ancestors in all, the oldest K910611 (1991). 14 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 5 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 4 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 3 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 2 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 1 generation backK034035 3I Patient-Specific Overdenture BarImplant Innovations, Inc. · 2004
- This deviceK080864 Cam Structsure Precision Milled BarsBiomet 3i, Inc. · 2008
- Descendant · cites it directly · 9 of its ownK180998 BioHorizons CAD/CAM BarsBioHorizons Implant Systems, Inc. · 2018
- Descendant · 2 generations on · 8 of its ownK203252 Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc. · 2021
- Descendant · 3 generations on · 3 of its ownK213106 BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl. · 2022
- Descendant · 3 generations on · 2 of its ownK240187 Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc. · 2024
- Descendant · 4 generations on · 2 of its ownK231827 BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl. · 2023
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K180998BioHorizons CAD/CAM BarsBioHorizons Implant Systems, Inc. · 2018 · cites it directly9descendants
- K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc. · 2021 · 2 generations on8descendants
- K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl. · 2022 · 3 generations on3descendants
- K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc. · 2024 · 3 generations on2descendants
- K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl. · 2023 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −5 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −4 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −3 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −2 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −1 | K034035 | 3I Patient-Specific Overdenture Bar | Implant Innovations, Inc. | 2004 | — |
| 0 (this device) | K080864 | Cam Structsure Precision Milled Bars | Biomet 3i, Inc. | 2008 | — |
| +1 | K180998 | BioHorizons CAD/CAM Bars | BioHorizons Implant Systems, Inc. | 2018 | — |
| +2 | K203252 | Multi-unit Abutments for CONELOG | BioHorizons Implant Systems, Inc. | 2021 | — |
| +3 | K213106 | BTI Interna Dental Implant System UnicCa - Prosthetic Components | B.T.I. Biotechnology Institute, Sl. | 2022 | — |
| +3 | K240187 | Tapered Pro Conical Implant System | BioHorizons Implant Systems, Inc. | 2024 | — |
| +4 | K231827 | BTI Dental Implant System UnicCa® – Aesthetic Post Abutments | B.T.I. Biotechnology Institute, Sl. | 2023 | — |
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 |
|---|---|---|
| 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 30.6 · 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 |
|---|---|---|---|
| * | K034035 | 3I Patient-Specific Overdenture BarSummary page 1…21 CFR § 872.3630 Device Classification: Class II Dental Devices Panel Legally Marketed Predicate K034035 3i Patient Specific Overdenture Bars Devices: 03127/08… | 2004 |
What descends from it? (14)
See all 143 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 13 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 21 ancestors has a recall of any class.
- Of its descendants, K180998 (BioHorizons Implant Systems, Inc., 2018) has gone furthest, with 9 descendants of its own.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 CAM StructSURE® Precision Milled Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080864 · printed Nov 5, 2026
Cite this page
510(k) Report. “K080864: Cam Structsure Precision Milled Bars.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080864
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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