510(k) · Cleared
ClearedAbutments for Competitive Implant Systems-Nobel Replace
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 Sep 1, 2011 as substantially equivalent to K020646 (Nobel Biocare Uas, Inc., 2002) and 2 other predicates after a 185-day review. Its family tree reaches back 5 generations to 1990. 10 later devices descend from it.
- Decided
- Sep 1, 2011
- Review
- 185 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K894595 (1990). 19 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 4 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 3 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 2 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 1 generation backK053654 Atlantis Abutment for Nobel Replace InterfaceAtlantis Components, Inc. · 2006
- This deviceK110565 Abutments for Competitive Implant Systems-Nobel ReplaceBiomet 3i, Inc. · 2011
- Descendant · cites it directly · 9 of its ownK112730 Abutment for Competitive Implant Straumann Bone Level ConnectionBiomet 3i · 2012 · Recalled
- Descendant · 2 generations on · 7 of its ownK181037 DIO CAD/CAM AbutmentDio Corporation · 2018
- Descendant · 3 generations on · 1 of its ownK222913 s-Clean Link AbutmentDentis Co., Ltd. · 2023
- Descendant · 3 generations on · 1 of its ownK210362 s-Clean Pre-Milled AbutmentDentis Co., Ltd. · 2021
- Descendant · 4 generations on · 0 of its ownK242703 LW Pre-milled AbutmentOssvis Co., Ltd. · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K112730Abutment for Competitive Implant Straumann Bone Level ConnectionBiomet 3i · 2012 · cites it directly9descendants
- K181037DIO CAD/CAM AbutmentDio Corporation · 2018 · 2 generations on7descendants
- K222913s-Clean Link AbutmentDentis Co., Ltd. · 2023 · 3 generations on1descendant
- K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd. · 2021 · 3 generations on1descendant
- K242703LW Pre-milled AbutmentOssvis Co., Ltd. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −4 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −3 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −2 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −1 | K053654 | Atlantis Abutment for Nobel Replace Interface | Atlantis Components, Inc. | 2006 | — |
| 0 (this device) | K110565 | Abutments for Competitive Implant Systems-Nobel Replace | Biomet 3i, Inc. | 2011 | — |
| +1 | K112730 | Abutment for Competitive Implant Straumann Bone Level Connection | Biomet 3i | 2012 | 2 |
| +2 | K181037 | DIO CAD/CAM Abutment | Dio Corporation | 2018 | — |
| +3 | K222913 | s-Clean Link Abutment | Dentis Co., Ltd. | 2023 | — |
| +3 | K210362 | s-Clean Pre-Milled Abutment | Dentis Co., Ltd. | 2021 | — |
| +4 | K242703 | LW Pre-milled Abutment | Ossvis Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K020646 | Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102…Summary page 1…lassification Name: Abutment, implant, denta, endosseous Device Classification/ Code: Class 11 21 CFR §872.3630 / NI-A Predicate Device: K020646, Nobel Replace HA Coated Implant K053654, Atlantis Abutment for Nobel Replace… | 2002 |
| * | K053654 | Atlantis Abutment for Nobel Replace InterfaceSummary page 1…ce Classification/ Code: Class 11 21 CFR §872.3630 / NI-A Predicate Device: K020646, Nobel Replace HA Coated Implant K053654, Atlantis Abutment for Nobel Replace Interface K023 113, Replac… | 2006 |
| * | K023113 | Replace Tiunite Endosseous ImplantSummary page 1…Coated Implant K053654, Atlantis Abutment for Nobel Replace Interface K023 113, Replace TiUnite Endosseous Implant Performance Testing: Performance testing was conducted as per Class I1… | 2002 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112730 | Abutment for Competitive Implant Straumann Bone Level Connection | 2012 | 9 |
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 21 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- 2 of the 19 ancestors have a recall of any class.
- Of its descendants, K112730 (Biomet 3i, 2012) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K020646.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
BIOMET 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained to the abutment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110565 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110565: Abutments for Competitive Implant Systems-Nobel Replace.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110565
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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