510(k) · Cleared
Recalled · Class II · 2020Modification to 3I Patient-Specific Dental Abutments and Overdenture Bars
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 Oct 20, 2005 as substantially equivalent to K032263 (Implant Innovations, Inc., 2004) after a 24-day review. Its family tree reaches back 6 generations to 1995. 17 later devices descend from it. It has been recalled 13 times.
- Decided
- Oct 20, 2005
- Review
- 24 days
- Class
- Class II
- Product code
- NHA
- Recalls
- 13
- Predicates
- 1
Its longest line of descent runs back 6 generations to K944964 (1995). 35 ancestors in all, the oldest K871863 (1987). 17 later devices descend from it, 4 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 backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- This deviceK052648 Modification to 3I Patient-Specific Dental Abutments and Overdenture…Implant Innovations, Inc. · 2005
- Descendant · cites it directly · 12 of its ownK141544 Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc. · 2014
- Descendant · 2 generations on · 8 of its ownK143505 Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc. · 2015
- Descendant · 3 generations on · 7 of its ownK181037 DIO CAD/CAM AbutmentDio Corporation · 2018
- Descendant · 2 generations on · 2 of its ownK160850 Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti · 2017
- Descendant · 4 generations on · 1 of its ownK222913 s-Clean Link AbutmentDentis Co., Ltd. · 2023
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc. · 2014 · cites it directly12descendants
- K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc. · 2015 · 2 generations on8descendants
- K181037DIO CAD/CAM AbutmentDio Corporation · 2018 · 3 generations on7descendants
- K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti · 2017 · 2 generations on2descendants
- K222913s-Clean Link AbutmentDentis Co., Ltd. · 2023 · 4 generations on1descendant
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 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| 0 (this device) | K052648 | Modification to 3I Patient-Specific Dental Abutments and Overdenture Bars | Implant Innovations, Inc. | 2005 | — |
| +1 | K141544 | Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant System | Zimmer Dental, Inc. | 2014 | — |
| +2 | K143505 | Zimmer Patient-Specific Abutment, Internal Hex, Titanium | Zimmer Dental, Inc. | 2015 | — |
| +3 | K181037 | DIO CAD/CAM Abutment | Dio Corporation | 2018 | — |
| +2 | K160850 | Nucleoss Tpure Implant System | Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti | 2017 | — |
| +4 | K222913 | s-Clean Link Abutment | Dentis Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 8 | 0 |
| 1994 | 7 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 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 |
|---|---|---|---|
| * | K032263 | 3I Patient-Specific Dental Abutment and Overdenture BarSummary page 1…vices Panel 21 CFR § 872.3630 Predicate 3i Patient-Specific Dental Abutments Devices K032263 Performance Performance standards have not been established by the FDA… | 2004 |
What descends from it? (17)
See all 174 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 31, 2020 | Class II | Z-0074-2021 | Device Design | Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct… |
| Aug 31, 2020 | Class II | Z-0077-2021 | Device Design | Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct… |
| Aug 31, 2020 | Class II | Z-0079-2021 | Device Design | Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct… |
| Aug 31, 2020 | Class II | Z-0073-2021 | Device Design | Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct… |
| Aug 31, 2020 | Class II | Z-0075-2021 | Device Design | Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct… |
| Aug 31, 2020 | Class II | Z-0076-2021 | Device Design | Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct… |
| Aug 31, 2020 | Class II | Z-0078-2021 | Device Design | Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct… |
| Feb 26, 2019 | Class II | Z-2141-2019 | Process control | During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop. |
| Feb 26, 2019 | Class II | Z-2142-2019 | Process control | During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop. |
| Feb 26, 2019 | Class II | Z-2143-2019 | Process control | During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop. |
| Feb 26, 2019 | Class II | Z-2140-2019 | Process control | During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop. |
| Feb 26, 2019 | Class II | Z-2144-2019 | Process control | During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop. |
| Aug 26, 2013 | Class II | Z-1215-2014 | Device Design | Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received. |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 5 of the 35 ancestors have a recall of any class.
- Of its descendants, K141544 (Zimmer Dental, Inc., 2014) has gone furthest, with 12 descendants of its own.
- 9 other devices also cite its predicate K032263.
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 Dental Abutments and Overdenture Bars are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. It is intend for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052648: Modification to 3I Patient-Specific Dental Abutments and Overdenture Bars.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052648
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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