510(k) · Cleared
Recalled · Class II · 2015Conical Angled Abutment
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 Mar 20, 2007 as substantially equivalent to K933462 (Implant Innovations, Inc., 1994) after a 131-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it. It has been recalled 5 times.
- Decided
- Mar 20, 2007
- Review
- 131 days
- Class
- Class II
- Product code
- NHA
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933462 (1994). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K101068Accufit Dental Implant Abutments & ScrewsRadiant Express, LLC · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933462 | Conical Abutment | Implant Innovations, Inc. | 1994 | — |
| 0 (this device) | K063403 | Conical Angled Abutment | Implant Innovations, Inc. | 2007 | — |
| +1 | K101068 | Accufit Dental Implant Abutments & Screws | Radiant Express, LLC | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 30.6 · 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 |
|---|---|---|---|
| * | K933462 | Conical AbutmentSummary page 1…Class If Classification Dental Devices Panel 21 CFR § 872.3630 Predicate Conical Abutment -> K933462 Devices Performance Performance standards have not been established by the F… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101068 | Accufit Dental Implant Abutments & Screws | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 25, 2015 | Class II | Z-2514-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2513-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2505-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2504-2016 | Packaging | Pouches may not have been sealed during packing. |
| Sep 28, 2011 | Not classified | Z-0158-2012 | Employee error | On 09/28/2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Conical Angled Abutment, Model # AC4425 Lot 887628-5 and their Standard Conical Abutment Cylinder Model # SWCA62 Lot 848478. The packaging for the referenced… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
3i's Conical Angled Abutments are indicated for use in single and multiple unit cases and as custom copings where tissue depth, as measured from the crest of the tissue to the shelf of the implant; angulation of the implant in relation to other implants or adjacent dentition; and, interarch distance measured form the shelf of the implant to the opposing dentition, provide for improved emergence profiles and contours for esthetic restorations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063403 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063403: Conical Angled Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063403
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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