510(k) · Cleared
Recalled · Class II · 2016Low Profile Abutments - Internal and External Connection
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 Nov 30, 2009 after a 118-day review. The FDA summary names its predicate without a number. 114 later devices descend from it. It has been recalled 39 times.
- Decided
- Nov 30, 2009
- Review
- 118 days
- Class
- Class II
- Product code
- NHA
- Recalls
- 39
- Predicates
- 0
114 later devices descend from it, 4 citing it directly.
- This deviceK092341 Low Profile Abutments - Internal and External ConnectionBiomet 3i, Inc. · 2009
- Descendant · cites it directly · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · 2 generations on · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- Descendant · 2 generations on · 38 of its ownK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- Descendant · 2 generations on · 22 of its ownK183518 Preat AbutmentsPreat Corporation · 2019 · Recalled
- Descendant · 2 generations on · 20 of its ownK212628 DESS Dental Smart SolutionsTerrats Medical SL · 2022
Showing 5 of 114 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 114 · See all- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · cites it directly86descendants
- K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · 2 generations on51descendants
- K191986DESS Dental Smart SolutionsTerrats Medical SL · 2019 · 2 generations on38descendants
- K183518Preat AbutmentsPreat Corporation · 2019 · 2 generations on22descendants
- K212628DESS Dental Smart SolutionsTerrats Medical SL · 2022 · 2 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K092341 | Low Profile Abutments - Internal and External Connection | Biomet 3i, Inc. | 2009 | — |
| +1 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +2 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| +2 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
| +2 | K183518 | Preat Abutments | Preat Corporation | 2019 | 3 |
| +2 | K212628 | DESS Dental Smart Solutions | Terrats Medical SL | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2020 | 8 | 0 |
| 2021 | 10 | 0 |
| 2022 | 11 | 0 |
| 2023 | 19 | 0 |
| 2024 | 18 | 0 |
| 2025 | 22 | 0 |
| 2026 | 12 | 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 |
|---|---|---|---|
| * | — | Conical Abutments (Straight and Angled) Named without a submission number | |
| * | — | Immediate Occlusal Loading (IOL) Abutments Named without a submission number | |
| * | — | Asyst Abutment Delivery Device Named without a submission number |
What descends from it? (114)
See all 1144 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 |
|---|---|---|---|---|
| Sep 14, 2016 | Class II | Z-0829-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0832-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0834-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0835-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0838-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0845-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0856-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0858-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0860-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0830-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0833-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0841-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0842-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0844-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0848-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0851-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0852-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0854-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0859-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0861-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0862-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0836-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0837-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0840-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0843-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0846-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0847-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0853-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0857-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0863-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0828-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0831-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0839-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0849-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0850-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Sep 14, 2016 | Class II | Z-0855-2017 | Employee error | A limited number of product pouches may not have been sealed during packaging. |
| Nov 25, 2015 | Class II | Z-2463-2016 | Packaging | Pouches may not have been sealed during packing. |
| Jan 10, 2012 | Not classified | Z-1456-2012 | Material/Component Contamination | Biomet 3i initiated a recall for a small percentage of the 33mm (ILPAC3217) abutment packages that may contain the 5mm (ILPAC5217) abutment. |
| Mar 14, 2011 | Not classified | Z-2884-2011 | Labeling mix-ups | Biomet 3i, Palm Beach Gardens, FL is recalling the Model LPCCC2 Low Profile Abutment, Non-Hexed Castable Cylinder, Lots 2010101036 and 2010101037 Exp. 10/2015. Package labeling may not correctly describe the package contents. Product was… |
The 5 latest of 39 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K170588 (Terrats Medical SL, 2017) has gone furthest, with 86 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. 2009, 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 Low Profile 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 is screw retained to the abutment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092341 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092341: Low Profile Abutments - Internal and External Connection.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092341
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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