510(k) · Cleared
ClearedCustom Bars
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implant Direct Sybron Manufacturing, LLC · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jul 24, 2017 as substantially equivalent to K122424 (Dentsply International, Inc., 2013) after a 306-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Jul 24, 2017
- Review
- 306 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K944964 (1995). 64 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 deviceK162633 Custom BarsImplant Direct Sybron Manufacturing, LLC · 2017
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 deviceK162633 Custom BarsImplant Direct Sybron Manufacturing, LLC · 2017
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) | K162633 | Custom Bars | Implant Direct Sybron Manufacturing, LLC | 2017 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K122424 | Isus Implant SuprastructuresSummary page 4…● Regulatory Class: II ● Product Code: NHA 3. PREDICATE DEVICES ● Dentsply International ISUS Implant Suprastructures (K122424) – Primary Predicate ● Nobel Biocare NobelProcera Overdenture Bar (K132749) – Reference ● Biomet 3i CAM… | 2013 |
| † | K132749 | Nobelprocera Overdenture Bar | 2014 |
| † | K101582 | Cam Structsure Bars | 2010 |
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 22 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 8 of the 64 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. 2017, 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?
Implant Direct Custom Bars are patient specific devices indicated for attachment to dental implants in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. Custom bars are compatible at the implant level with InterActive (3.4mm Platform) & SwishActive (3.4 Platform) System implants. Manufacturer Implant Line Body Diameter Implant Platform Implant Direct InterActive 4.3mm, 5.0mm 3.4mm Implant Direct…
Read the full statement (99 words)
Implant Direct Custom Bars are patient specific devices indicated for attachment to dental implants in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function.
Custom bars are compatible at the implant level with InterActive (3.4mm Platform) & SwishActive (3.4 Platform) System implants.
Manufacturer Implant Line Body Diameter Implant Platform
Implant Direct InterActive 4.3mm, 5.0mm 3.4mm
Implant Direct SwishActive 4.8mm 3.4mm
Custom bars are compatible at the abutment level with InterActive (3.4mm Platform) & SwishActive (3.4 Platform) system straight multi-unit abutments.
Manufacturer Implant Line Implant Platform
Implant Direct InterActive 3.4mm
Implant Direct SwishActive 3.4mm
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162633 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162633: Custom Bars.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162633
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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