510(k) · Cleared
ClearedCustom Legacy and Custom InterActive Titanium Abutments
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 May 8, 2020 as substantially equivalent to K060063 (Implant Direct, LLC, 2006) after a 267-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- May 8, 2020
- Review
- 267 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011028 (2001). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K060063 | Legacy Abutment SystemSummary page 4…Class II Product Code: NHA Predicate Device: Implant Direct Sybron Manufacturing, LLC’s Legacy Abutment System (K060063) Reference Devices: Implant Direct Sybron Manufacturing, LLC’s InterActive/SwishPlus2 Implant System (K130572) 3Shape A/S’s… | 2006 |
| † | K130572 | Interactive/ SWISHPLUS2 Implant System | 2013 |
| † | K151455 | 3Shape Abutment Designer Software | 2016 |
| † | K181359 | InterActive SMARTBase Abutments | 2018 |
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 19 years and passes through 3 companies; a new generation was cleared every 14.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Custom Titanium Abutments are customizable devices intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients. • Custom Titanium Abutment for narrow (3.2mmD, 3.3mmD) implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements. • Custom…
Read the full statement (183 words)
Custom Titanium Abutments are customizable devices intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.
• Custom Titanium Abutment for narrow (3.2mmD, 3.3mmD) implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements.
• Custom Titanium Abutment for short (8mm) 3.7mmD implants: Indicated for tooth replacement of mandibular and maxillary central and lateral incisors.
Custom Legacy Titanium Abutments are compatible at the implant-level with Legacy1, Legacy2, Legacy3, Legacy4, simplyLegacy2 and simplyLegacy3 implants, excluding 6mm length implants.
Implant Line Body Diameter Platform Diameter Implant Length
Legacy1 3.7mm, 4.2mm, 4.7mm, 5.7mm 3.5mm, 4.5mm, 8mm to 16mm
5.7mm
Legacy2, Legacy3, Legacy4, 3.2mm, 3.7mm, 4.2mm, 3.0mm, 3.5mm,
simplyLegacy2, simplyLegacy3 4.7mm, 5.2mm, 5.7mm, 7.0mm 4.5mm, 5.7mm
Custom InterActive Titanium Abutments are compatible at the implant-level with InterActive, SimplyInterActive and SwishActive implants, excluding 6mm length implants.
Implant Line Body Diameter Platform Diameter Implant Length
InterActive, simplyInterActive 3.2mm, 3.7mm, 4.3mm, 5.0mm 3.0mm, 3.4mm 8mm to16mm
SwishActive 3.3mm, 4.1mm, 4.8mm 3.0mm, 3.4mm 8mm to16mm
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192218: Custom Legacy and Custom InterActive Titanium Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192218
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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