510(k) · Cleared
ClearedTSV BellaTek Encode Healing Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet 3i · NHA Abutment, Implant, Dental, Endosseous
Cleared on Dec 13, 2017 as substantially equivalent to K170013 (Biomet 3i, 2017) after a 47-day review. Its family tree reaches back 2 generations to 2007. 2 later devices descend from it.
- Decided
- Dec 13, 2017
- Review
- 47 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K072642 (2007). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK072642 Biomet 3I Dental Abutments and Restorative ComponentsBiomet 3i, Inc. · 2007 · Recalled
- 1 generation backK170013 Eztetic BellaTek Encode Healing AbutmentsBiomet 3i · 2017
- This deviceK173374 TSV BellaTek Encode Healing AbutmentsBiomet 3i · 2017
- Descendant · cites it directly · 0 of its ownK232383 iPhysio® SystemEuroteknika · 2025
- Descendant · cites it directly · 0 of its ownK212730 BellaTek Encode Emergence Healing AbutmentsBiomet 3i, LLC · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K072642 | Biomet 3I Dental Abutments and Restorative Components | Biomet 3i, Inc. | 2007 | 81 |
| −1 | K170013 | Eztetic BellaTek Encode Healing Abutments | Biomet 3i | 2017 | — |
| 0 (this device) | K173374 | TSV BellaTek Encode Healing Abutments | Biomet 3i | 2017 | — |
| +1 | K232383 | iPhysio® System | Euroteknika | 2025 | — |
| +1 | K212730 | BellaTek Encode Emergence Healing Abutments | Biomet 3i, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K170013 | Eztetic BellaTek Encode Healing AbutmentsSummary page 4….3630, Class 11 Product Code NHA Classification Panel: Dental Products Panel Reviewing Branch: Dental Devices Branch PREDICATE DEVICE INFORMATION Primary Predicate: K170013 Eztetic™ BellaTek"™ Encode” Healing Abutments Biomet 3i Reference Predicates for Compatibility: K061410 Zimmer Dental Implant S… | 2017 |
| † | K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant… | 2006 |
| † | K133339 | Zimmer Dental Tapered Screw Vent T Implant, HA Coated;Zimmer Dental Tapered Screw-Vent M… | 2014 |
| † | K113753 | Zimmer Dental Tapered Screw-Vent X | 2012 |
| † | K132258 | Zimmer Dental Trabecular Metal Implant System | 2013 |
What descends from it? (2)
2 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)
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 10 years and passes through 2 companies; a new generation was cleared every 9.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K232383 (Euroteknika, 2025) has gone furthest, with 0 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. 2017, 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?
The TSV™ BellaTek™ Encode® Healing Abutments are intended for use as an accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tissue for acceptance of a final abutment and restoration.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173374 · printed Nov 5, 2026
Cite this page
510(k) Report. “K173374: TSV BellaTek Encode Healing Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K173374
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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